SlideShare a Scribd company logo
1 of 50
Example of Quality
Manual
1.0 Company Profile
Include your company profile
1.1 The mission of the Firm
Our mission is to enhance mobility through innovation, leadership,
and public service. Innovation by providing unparalleled value
combined with flexibility and risk-taking ability, leadership by
delivering exceptional performance in every domain, and corporate
responsibility through service to society.
1.2 The vision of the Firm
To strive relentlessly with an aim to achieve excellence in all
businesses that we venture into, with the objective of becoming an
organization that all its employees and associates are proud of.
2.0 Organization Scope
Design, Development of Land, Construction Sales of
Residential and Commercial Complexes
2.1 Exclusions:
NIL
2.1 Quality Policy
XXX is committed to delivering quality construction work with
promised amenities, in time possession, which meets and exceeds the
needs & expectations of our customers. We promise our valued
customer’s commitment to excellence in each activity by each
employee in the organization by adopting innovative and best in class
engineering and management practices with continual improvement
in business and quality management system as a part of our efforts
for enhancement in customer satisfaction while assuring 100% quality
and quantity.
2.2 Key Objectives
 Timely completion of projects
 Increase Customer satisfaction
 Reduce Customer Complaint
3.0 Glossary & Abbreviations
Sr.No. Abbreviation Description
Sr.
No.
Abbreviation Description
1 XXX Name of Company 18 ASL Approved supplier list
2 QSM
Quality System
Manual
19 PDIR Pre Despatch Inspection Re
3 DI
Documented
Information
20 MME
Measuring & Monitoring
Equipments
4 CFT
Cross-Functional
Team
21 ISO
International Organizationa
Standardization
5 CH Chart 22 MKT Marketing
6 CP Control Plan 23 QA Quality Assurance
7 FG Finished Goods 24 PUR Purchase
8 QF Quality Format 25 STR Stores
9 SYS System 26 PRD Production
10 IA Internal Audit 27 HR Human Resource
11 List List 28 MNT Maintenance
12 NC Non Conformance 29 DD Design and Development
13 CA Corrective action 30 LOI Letter of Indent
14 OK
Organizational
Knowledge
31 MI Measurement traceability
15 NCP
Non-Conforming
Product
32 PI Performance evaluation
16 NCR
Non Conformance
Report
33 MRM Management review meeting
17 EP External provider 34 IP Interested Parties
4.0 Context of Organization
4.1 Understanding the organization and its context:
Shah Promoters and Developers determine external and internal
issues that are relevant to its purpose and its strategic direction and
that affect its ability to achieve the intended result(s) of its quality
management system through PEST and SWOT. The external and
internal issues identified through PEST and SWOT are continuously
being monitored and reviewed by the CEO.
PEST
Political Factors (P)
1. Political direction on Smart Cities
2. Allocation for Infrastructure
3. Skill enhancement in Automation Sector
4. Monetary policies
Economic Factors (E)
1. The growth of banks in rural areas
2. Funding for smart cities
3. Increase in car park density
4. High GDP growth
Social Factors (S)
1. Increased literacy
2. Technological awareness
3. Banking on banks
4. Increased per capita income
Technology Factors (T)
1. Advancement in chip design
2. Automation tools growth
3. High technology at low cost
4. Digital technology growth
SWOT
Strength (S)
1. Strong technology backup
2. Young and motivated team
3. Nil borrowing
4. Quick decision making
5. Strong customer focus
Weakness
1. Very small team
2. Lack of experience
3. Weak marketing
4. High inventory
5. Limited customer base
Opportunity (O)
1. Lean organization leads to
1. Flexibility in products
2. Quick response to customer needs
Threat (T)
1. High technology imports
2. Skill development velocity
3. Increased competition
4. Technology leakage
2. Low level of competition
3. High growth potential
5. Attrition
4.2- Understanding the needs and expectations of interested
parties
xxx has determined the interested parties who are relevant to the xxx
Quality management system and the requirement of the interested
parties in order to prevent the potential effect on the organization’s
ability to consistently provide products and services which meet the
customer and applicable statutory and regulatory requirements.
Interested
parties
Requirements Monitoring & Review mechani
External
providers
1. Specification communication
2. Payment as agreed
3. On time Supply of Input material (if any)
4. Technology support
1. Defined in the Documented
information of External
providers control
2. Review in Management rev
meetings
Customer
1. Quality of product & Service
2. Delivery of product on time
3. Response to complaint
4. Proper Communication channel
1. Defined in the documented
information of Marketing &
Sales process
2. Review in Management rev
meetings
Statutory &
Regulatory Body
Complying with the statutory and regulatory
requirements as defined from time to time.
1. Defined in the documented
information of Leadership
2. Review in Management rev
meetings
Bankers /
Financiers
Updating of changes in the organization
whenever it happened
Review in Management review
meetings
Employees Management Support, Payments on time Accounting Control of managem
4.3 Determining the scope of the quality management
system
The organization had determined the scope of the Quality
management system by considering external and internal issues, the
requirement of relevant interested parties and Product & Service of
the organization.
The scope of Quality Management System is
Design, Development of Land, Construction Sales of
Residential and Commercial Complexes
Exclusions:
NIL
4.4 Quality management system and its processes
4.4.1: xxx has determined the processes needed for the quality
management system and their application throughout the
organization in Process map & Interactions of processes.
xxx has determined the inputs required and the outputs expected from
each process in an individual process map addressed in the
documented information of each process.
xxx has determined the sequence and interaction of the processes in
Process map & Interactions of processes.
xxx has determined and applied the criteria and methods (including
monitoring, measurements, and related performance indicators)
needed to ensure the effective operation and control of these processes
in the documented information of each process.
xxx has determined the resources needed for these processes and
ensures their availability in the documented information of
the Support process.
xxx has assigned the responsibilities and authorities for each process
xxx has addressed the risks and opportunities
xxx has been evaluating these processes and implementing any
changes needed to ensure that these processes achieve their intended
results and improve the processes and the quality management
system
Improve the processes and the quality management system
4.4.2- xxx is also maintaining documented information to support the
operation of its processes and retaining documented information to
have confidence that the processes are being carried out as planned.
5.0 Leadership
5.1 Leadership and commitment
Xxx Management has demonstrated leadership and commitment
with respect to the quality management system through
1. Taking accountability for the effectiveness of the quality
management system by periodical review of quality management
system through management review meeting, Quality objectives
review and providing necessary resources.
2. Management has established the quality policy and quality
objectives for the quality management system and is compatible
with the context and strategic direction of the organization.
3. Management has determined the organizational processes and
integrated with the quality management system requirement
through process map & Interaction this can be demonstrated.
4. The established procedure for promoting the use of the process
approach and risk-based thinking.
5. Ensuring that the resources needed for the quality management
system are available, this is being periodically reviewed through
management review meeting.
6. Communicating the importance of effective quality management
and of conforming to the quality management system
requirements
7. Ensuring that the quality management system achieves its
intended results
8. Engaging, directing and supporting persons to contribute to the
effectiveness of the quality management system by providing
training, conducting awareness programs and
9. Promoting improvement by introducing the suggestion scheme,
Kaizens and conducting meetings.
10. Supporting other relevant management roles to demonstrate
their leadership as it applies to their areas of responsibility.
5.1.2 Customer focus
Xxx management has demonstrated leadership and commitment
with respect to customer focus by ensuring that:
1. Customer and applicable statutory and regulatory requirements
are determined, understood and consistently met.
2. The risks and opportunities that can affect conformity of
products and services and the ability to enhance customer
satisfaction are determined and addressed
c) The focus on enhancing customer satisfaction is maintained and
procedure for customer satisfaction is addressed
5.2 QUALITY POLICY
XXX is committed to delivering quality construction work with
promised amenities, in time possession, which meets and exceeds the
needs & expectations of our customers. We promise our valued
customer’s commitment to excellence in each activityby each employee
in the organization by adopting innovative and best in class engineering
and management practices with continual improvement in business
and quality management system as a part of our efforts for
enhancement in customer satisfaction while assuring 100% quality and
quantity. We are also committed to serving society as a whole by
generating through a clean development mechanism (CDM) project.
5.2.1 Establishing the quality policy
Xxx management has established, implemented and maintained a
quality policy that:
1. is appropriate to the purpose and context of the organization and
supports its strategic direction.
2. Provides a framework for setting quality objectives
3. Includes a commitment to satisfy applicable requirements
4. Includes a commitment to continual improvement of the quality
management system
5.2.2 Communicating the quality policy
The quality policy is
1. Available and be maintained as documented information
2. Communicated, understood, and applied within the organization
through the display, Training, and periodical review.
3. Available to relevant interested parties, as appropriate.
5.3 Organizational roles, responsibilities and authorities
Xxx management has ensured that the responsibilities and
authorities for relevant roles are assigned communicated and
understood within the organization. While assigning roles,
responsibility, and authority, top management has considered and
ensured that
1. The quality management system conforms to the requirements of
this International Standard
2. The processes are delivering their intended outputs
3. Reporting on the performance of the quality management system
and on opportunities for improvement, in particular, to top
management
4. The promotion of customer focus throughout the organization
5. The integrity of the quality management system is maintained
when changes to the quality management system are planned and
implemented.
Roles, responsibility and authorities assigned are available in process
& as per Organization chart wise
Directors
Responsibility
 Overall Responsibility for formulating and communicating
Quality Policy & Quality objectives.
 Formulation of Strategy for continuous up gradation of Business
and Quality System.
 Ensure periodic assessment of the performance of Quality System.
 Approval of Quality System Manual.
 Budget Approval for the organization.
 Overall Responsibility for Business Development & all financial
issues.
 Provision of resources as required.
 Strategic decisions on developments and technical setups.
 To provide the leadership for efficient implementations of the
system.
Authorities:
 Approval of customers orders, P.O. and Cheque.
 Sanctioning leaves of all Staff.
 Approval of funds for Training needs.
 All the authorities of downline personnel.
 Chairing Management review meetings.
Project Planning
Responsibilities:
 Overall coordination between client, project managers and office
department.
 Follow up for Schedules.
 The entire responsibility of Quality.
 Monitoring Client Satisfaction.
 Coordination with the consultants.
 Disciplinary actions against the staff.
 Prime responsibility for the safety at the site
 Provision of a suitable working environment
 Ensure the quality system is established, implemented and
maintained.
Authorities:
 Appointment of the staff, engineers and tech staff.
 Sanctioning the Leaves to Staff.
 All the authorities of downline personnel.
Project Managers
Responsibilities:
 Responsibilities for the entire Project work, i.e. Quality, Quantity
and Time.
 Coordination with consultants and contractors.
 Coordination with Consultants for drawings.
 Coordination with the Site engineers.
 Coordination with the client for the ongoing changes in drawings
and projects.
 Monitoring site engineers work on a daily basis.
 Reporting to the GM Projects on the above issues
 Responsibilities for safety at the site. (Good working
environment).
Authorities:
 Make or force a required decision at all levels to achieve project
objectives.
 Initiate actions on the Contractors and consultants for Quality,
Quantity and Timeframe issues related to project work.
 To stop and initiate corrective actions on non–confirming
products/services.
Site Supervisor
Responsibilities:
 Coordinating with all staff for the Quality related issues of
Construction.
 Daily Labour Handling for Civil Work.
 Monitoring of Work progress and daily reporting.
 Preparation of work progress report / Quality Documentation.
 Control of non – conformities on site
 Safety at site / Construction work.
 Coordination with the Site Contractor for the daily work
requirements.
 Coordination with external agencies for calibration of
instruments and material testing.
Authorities:
 Initiate actions on the staff for non-fulfillments of the
documentation related quality
 To stop and initiate corrective actions on non–conforming
products.
Site engineer
Responsibilities:
 Monitoring of site and labour contractors.
 Monitoring of work progress and daily reporting
 Preparation of work progress report.
 Control of non – conformities on site.
 Ensuring instruments are properly used and are with the status of
calibration.
 Track Project progress & produce regular weekly status reports.
 Coordinate with all labour contractors to achieve continuous
progress at the site as per schedule.
 Follow up with the Project manager for pending
decisions/drawings/building specifications.
 Communicate management decisions and information to Site
subordinate staff.
 Ensuring the worker’s safety at site and usage of safety equipment.
 Implementation and follow up and regular monitoring of
implemented ISO 9001 system at the site.
 Coordination with the Quality Person for Quality related issues.
 Coordinating Material Accountability at site
Authorities:
 Initiating the corrective and preventive actions as needed on
contractors and consultants.
 Decision making on during any emergencies at the site.
In-charge Marketing:
Managing & motivating the sales force towards the achievement of
target.
 Preparation of Sales plan.
 Annual sales forecast.
 Monthly sales forecast.
 Implementation of sales plan.
Authorities:
 Approval of documents as per the Master list of Quality System
Document.
 Authorized to decide corrective & preventive action.
 Authorized to obtain concessional acceptance for non –
conforming product from the customer.
InCharge – ADMIN + ACCOUNT
Responsibilities:
 Responsible for tendering activity.
 Customer order review.
 Handling and coordinating customers
 Identification of resources, as applicable.
 Document & Data control system pertaining to his department.
 Maintain all documents related to the quality system.
 Coordinator for Management reviews.
 Promoting awareness of customer requirements throughout the
Organization.
 Compliance & effectiveness of the training system.
 Suitable working environment (cleanliness, ventilation, lighting,
safety etc.).
 Record maintaining for Sales Register, Rent Register, Sale Files,
Stationery and Office equipment.
 Archiving and record keeping of old files.
 Payroll Monthly: Salary –To release monthly salary of the
employees as per policy finalized.
 Leave – To keep the record of leave as per policy finalized.
 Annual Allowance – To release annual allowances as per policy
finalized.
 Employee Record – To update employee details as per
organization Policy and QMS.
 To prepare an appointment letter, confirmation letter, experience
letter & all employee-related matter as per policy finalized with the
help of the Managing Director.
Authorities:
 Approval of customer orders.
 Approval of documents as per the master list of Quality System
Document.
 Authorized to decide corrective & preventive action.
In charge Purchase:
Responsibilities:
 Overall in charge of purchase activities.
 Identification of resources, as applicable.
 Purchasing system – Evaluation, selection, purchasing,
monitoring.
 Document & Data control system pertaining to his department.
 Corrective / Preventive action system (subcontractor non-
conformances, in particular.)
 Control of records
Authorities:
 Authorized to review & approve purchasing documents.
 Authorized to select & discontinue sub-contractor
6.0 Planning
6.1 Actions to address risks and opportunities
6.1.1
Xxx is addressed the issues, requirements the risks and opportunities
1. give assurance that the quality management system can achieve
its intended result(s)
2. Enhance desirable effects
3. Prevent, or reduce undesired effects
4. achieve improvement
6.1.2
1. actions to address these risks and opportunities
2. How to
1. integrate and implement the actions into its quality
management system processes
2. Evaluate the effectiveness of these actions
Interested parties Requirements
Risks and
Opportunities
Effectiveness of action
External providers
Communication, Payment
Terms, On Time Supply,
Technology Support,
Communication
Gap, Payment &
Delivery terms not in
written, Output
Failure
Communication
like Emails, Phone,
Payment & delivery te
mention in PO,
Documented informati
provided for
Technical support
Customer
Product Quality, Delivery
& service
of on time, Response to
the complaint, Proper
Communication channel
Business Loss,
Reputation Down for
Organization
Defined in the documen
information of Marketi
& Sales process & Rev
in Management review
meetings
Statutory &
Regulatory Body
Organization & product
related Statutory &
regulatory requirements
are kept
The customer is not
acceptable material or
loss of business
Defined in documented
information & Review
Management review
meetings
Bankers/financiers
All product &
organization related
documents are kept
The organization is
facing the problems
(funds related)
All product & organiza
related documents are
Employees On time Payments
Work is not properly
operated
On time payments issu
employees
Marketing
Competitive rates, More
amenities, Prime
Location,
Organization facing
problems in sales,
Reputation in market
Market analysis,
Competent marketing t
Purchase
Competitive rates, Good
Quality material, Timely
Delivery,
The organization
facing Finance
problems, Customer
dissatisfied, Delay in
project completion
& Reputation
in market
Market analysis,
Competent Purchase
6.2.2 Quality objectives and planning to achieve them
6.2.1 Xxx establishes quality objectives at relevant functions, levels,
and processes needed for the quality management system.
The quality objectives shall
1. Be consistent with the quality policy
2. Be measurable
3. Take into account applicable requirements
4. Be relevant to the conformity of products and services and to the
enhancement of customer satisfaction
5. Be monitored
6. Be Communicated
7. Be updated as appropriate
6.2.2 Xxx achieve its quality objectives,
1. What will be done?
2. What resources will be required?
3. Who will be responsible?
4. When it will be completed
5. How the results will be evaluated
Our Quality Objectives are as below:
 Timely completion of projects
 Energy Generation Per Year
 Increase Customer satisfaction
 Reduce Customer Complaint
6.3 Planning of changes
Xxx determines the need for changes to the quality management
system, the changes are carried out in a planned manner
1. the purpose of the changes and their potential consequences
2. the integrity of the quality management system
3. the availability of resources
4. the allocation or reallocation of responsibilities and authorities
Xxx has determined the processes needed for the quality management
system and their application throughout the organization in Process
map & Interactions of processes
7 Support
7.1 Resources
7.1.1 General
Xxx is determined and provides the resources needed for the
establishment, implementation, maintenance, and continual
improvement of the quality management system. Xxx is consider
1. the capabilities of, and constraints on, existing internal resources
2. what needs to be obtained from external providers
HR determine and provide the resources needed to implement and
maintain the quality management system and continually improve its
effectiveness and to enhance customer satisfaction by meeting
customer requirement. The resources will be in the form of
 Human resources including qualified personnel for verification
activities.
 Manufacturing machines, Test Equipment’s & infrastructure.
 Provide raw material & other inputs for the realization of the
product.
 Providing funds.
The Required resources are identified in the event of new Process
Development / Business plan review, Mfg Process Flow, also based on
the Organization performance review in MRM and monthly business
reviews.
7.1.2 People
Xxx determines and provides the persons necessary for the effective
implementation of its quality management system and for the
operation and control of its processes. HR along with respective
processes IN CHARGE ensures that personnel performing work
affecting product quality is competent and training to give on the
basic operation and control of its processes.
7.1.3 Infrastructure
Xxx is determined, provide and maintain the infrastructure
necessary for the operation of its processes and to achieve conformity
of products and services. Infrastructure can include
1. buildings and associated utilities
2. equipment, including hardware and software
3. transportation resources
4. information and communication technology
At Xxx management determine, provide and maintain the
infrastructure needed to achieve conformity to product requirements
& in identifying the required resources the PARTNER play a key role
based on their day to day interactions with respective IN CHARGE’s
and employees
7.1.4 Environment for the operation of processes
Xxx is determined, provide and maintain the environment necessary
for the operation of its processes and toachieve conformity of products
and services. A suitable environment can be a combination of human
and physical factors
1. Social (e.g. non-discriminatory, calm, non-confrontational)
2. Psychological (e.g. stress-reducing, burnout prevention,
emotionally protective)
3. Physical (e.g. temperature, heat, humidity, light, airflow,
hygiene, noise).
Project in coordination with respective IN CHARGE determines and
manages the work environment needed to achieve conformity to
product requirement and reviewed ongoing basis.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
Xxx is determined and provides the resources needed to ensure valid
and reliable results when monitoring or measuring is used to verify
the conformity of products and services to requirements. The
organization shall ensure that the resources provided
1. are suitable for the specific type of monitoring and measurement
activities being undertaken
2. are maintained to ensure their continuing fitness for their
purpose
Xxx is retained appropriate documented information as evidence of
fitness for purpose of the monitoring and measurement resources
7.1.5.2 Measurement traceability
Xxx is measurement traceability is maintained requirement if
applicable for the instruments or is considered by them to be an
essential part of providing confidence in the validity of measurement
results,
1. calibrated or verified, or both, at specified intervals, or prior to
use, against measurement standards traceable to international or
national measurement standards; when no such standards exist,
the basis used for calibration or verification shall be retained as
documented information
2. identified in order to determine their status
3. safeguarded from adjustments, damage or deterioration that
would invalidate the calibration status and subsequent
measurement results
Xxx is determined the validity of previous measurement results has
been adversely affected when measuring equipment is found to be
unfit for its intended purpose, and shall take appropriate action as
necessary.
Control of Monitoring & Measuring Equipments.
The measurement & Monitoring system is well equipped and the
system has complete control over the monitoring and Measuring
Equipment. The measurement methods used are evaluated to ensure
that they are appropriate and reliable. To ensure that the measuring
equipment operates effectively and give reliable results, we have taken
the following steps:
 Equipments are maintained properly and are calibrated &
adjusted as and when needed. Necessary safeguards are in place
to take care of adjustments that could lead to invalid results.
 Calibrations are carried out as per national standards (by NABL
accredited laboratories only). Where no such standard exists, the
basis used for calibration or verification is recorded. The
calibration records include the last date of calibration, calibrating
agency (for the external agency), calibration result, and frequency
of calibration as per the process and/or instrument requirement
and the next calibration date. The required accuracy is identified
and compared to the measurement that meets expectations.
 Identification of appropriate equipment is accomplished by
tagging, labelling, numbering or by including it in a
calibration/maintenance database.
 Proper control is maintained to ensure that no faulty equipment is
used, the reliability of the equipment is ensured through routine
maintenance and re-calibration.
 Equipments are used, handled and stored under conditions that
protect the accuracy and prevent. Unauthorized adjustment. Work
environmental controls are all in place for equipment.
 Instrument history cards are maintained for all measuring &
Test Instruments.
Laboratory Requirements
Internal Laboratory
The internal laboratory is available as on date the various test is
carried out as per customer requirement, standard specification and
internal laboratory test procedure are available & the record is kept.
External Laboratory
 External / Commercial/independent laboratory facilities used by
IM will be accredited laboratory facilities to NABL or NPL or as
accepted by the Customer.
 Evidence of acceptance by national accreditation or customer
shall be kept.
7.1.6 Organizational knowledge
Xxx is determined the knowledge necessary for the operation of its
processes and to achieve conformity of products and services. This
knowledge shall be maintained and be made available to the extent
necessary. When addressing changing needs and trends, the
organization shall consider its current knowledge and determine how
to acquire or access any necessary additional knowledge and required
updates. Organizational knowledge is specific to the organization; it
is generally gained by experience. It is information that is used and
shared to achieve the organization’s objectives.
Organizational knowledge can be based on:
1. Internal sources (e.g. intellectual property; knowledge gained
from experience; lessons learned from failures and successful
projects; capturing and sharing undocumented knowledge and
experience; the results of improvements in processes, products and
services);
2. External sources ( e.g. standards; academia; conferences;
gathering knowledge from customers or external providers).
7.2 Competence
Xxx is
1. Determine the necessary competence of person(s) doing work
under its control that affects the Performance and effectiveness of
the quality management system
2. Ensure that these persons are competent on the basis of
appropriate education, training, or Experience
3. Where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions taken
Retain appropriate documented information as evidence of
competence for all employees
7.3 Awareness
Xxx is ensured that persons doing work under the organization’s
control are aware of
1. The quality policy
2. Relevant quality objectives
3. Their contribution to the effectiveness of the quality management
system, including the benefits of improved performance
4. The implications of not conforming to the quality management
system requirements
7.4 Communication
Xxx is determined the internal and external communications
relevant to the quality management system, including
1. On what it will communicate
2. When to communicate
3. With whom to communicate
4. How to communicate
5. Who Communicates
INTERNAL
COMMUNICATION
What When with whom How Who
Quality policy Permanent
All Employees /
Interested parties
Display /
Letter /
Training
Manage
Importance of effective
QMS
As per the Training
plan / during
Orientation training
All Employees
Training /
Display
Manage
Responsibilities and
Authority
During recruitment /
Promotion /
Department change
Employee
Procedure /
Oral /
Training
Manage
Quality objectives
While defining /
Once in 3 months
All employees
Procedure /
Oral /
Training
Manage
Customer complaint /
Feedback
At the time of receipt
Head of the
department /
Respective process
owner
Meeting Director
External
COMMUNICATION
What When with whom How Who
Information to external
providers
Placing purchase
order / Quotation
collection
Supplier
(External
provider)
Purchase order /
Letter / Email /
Oral
Purch
I/C
Product information Enquiry stage Customer
Email / Website /
Catalogue / Letter
Direct
Enquiry, order,
amendments
Enquiry review /
Order review
Customer
Electronic media /
Letter/ oral
Direct
Customer feedback
Once in a year /
After service
Customer
Forwarding
customer feedback
form
Direct
The action is taken for
customer complaints
Once the action is
taken
Customer
Electronic media /
Letter/ oral
Direct
Information to external
providers
As agreed with the
customer
Customer
Delivery challan /
Letter / Email
Stores
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
XXX creating and updating documented information, the XXX is
ensured appropriate
a) Identification and description
b) Format (e.g. language, software version, graphics) and media
(e.g. paper, electronic)
c) Review and approval for suitability and adequacy
XXX’s quality management system is included
Quality Management System documentation is established with the
following approach. A four-level-documented structure is followed for
the operation of the Quality Management System.
L-
1
QUALITY MANUAL (Standard Requirement)
L-
2
PROCEDURES
L-
3
PROCESS FLOW CHART, WI, QUALITY PLANS, CHECKSHEETS, MANUFACTURING
PROCESS FLOW CHARTS
L-
3
DOCUMENTED INFORMATION
 Level 1: Quality Manual (standard Requirement) Defines the
approach and responsibility, which includes a documented
statement of quality policy & objectives etc.
 Level 2: Procedures
Defines what, where, when, who & why of an activity being done
as stated in ISO- 9001:2015 standard. The documented procedure
activity process flowchart defines the effective planning, operation
and control of processes.
 Level 3: WI, Quality Plans, Check sheet etc
Defines how exactly an activity is to be done ensuring the effective
planning, operation and control of processes.
 Level 4: Documented Information
Provides the evidence, which has to be established for all the
activities, stated above which In turn Documented Information. A
master list of Quality Record is maintained by respective
Departments/ section heads as per the requirement of ISO
9001:2015.
Control of Quality System Manual.
 Partner is approved the Quality Manual, procedure, WI &
documented Information and its amendments.
 Management Representative / Quality In charge is responsible for
the preparation, review, issue & control of the manual and its
amendments.
 In case any person ceases to be the holder of manual copy for any
reason, his copy number of manual will be allocated to any new
holder with the note in amendment list to this effect.
 MASTER COPY will be stamped “MASTER” on the front side
of all pages in “BLUE”
 A photocopy will be taken for all MASTER & will
be “CONTROLLED” stamped in RED MR/Quality in charge
maintains the master copy having original signatures.
Document changes.
MR/Quality in charge perceives the need for the amendment to this
manual based on the adequacy audit report, mistake/corrections
during review by any holder, system change, and an amendment to
reference ISO standard or any change in the organization affecting
system described in this manual. Amendments to this manual are
recorded in the Amendment list (After Amendment).
The holders of the Quality System Manual refer to the amendment list
before referring to respective amended sections to clearly understand
the details/purpose of the amendment. A list indicating the latest
revision status of each page of this manual, whenever a page of any
chapter is amended, the page and the chapter bear the latest Rev. No.
The latest revision no. is indicated in the amendment sheet, and on the
cover page of the Quality Manual. The revised version of the document
pages is sent only to the holders as along with the updated amendment
list and revision status page.
Controlled copyholders of this manual should ensure that the obsolete
pages are removed & destroyed and revised pages are inserted in the
Manual at appropriate places. Management Representative / Quality
In-charge maintains one copy of the obsolete version of revised pages
at the time of each amendment for reference purposes and having
the OBSOLETE stamp in RED color. When the Rev. No. Of
the Amendment, sheet reaches 09, or in case an amendment to ISO
standard is released, the entire manual will be reissued and bear
the next serial number of issue no. No details of amendments to earlier
issue and recorded in amendment list for the new issue.
Numbering Logic Of Quality System Manual :
The numbering logic of this quality system manual will be as
described here:
1. The numbering logic will be -QM-XX.
2. indicates xxx.
3. QM indicates Quality System Manual of ISO 9001:2015.
7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality
management system and by this International Standard shall be
controlled to ensure
1. It is available and suitable for use, where and when it is needed.
2. It is adequately protected (e.g. from loss of confidentiality,
improper use, or loss of integrity)
7.5.3.2 For the control of documented information, xxx is address
the following activities, as applicable
1. Distribution, access, retrieval and use
2. Storage and preservation, including preservation of legibility
3. Control of changes (e.g. version control)
4. Retention and disposition
Documented information of external origin determined by the
organization to be necessary for the Planning and operation of the
quality management system is identified as appropriate and is
controlled. Documented information retained as evidence of
conformity shall be protected from unintended alterations.
8 Operation
8.1 Operational planning and control
Xxx will plan, implement and control the processes needed to meet the
requirements for the provision of products and services, and to
implement the actions in & maintained risks and opportunities related
to planning maintained in operational planning control. The bar
chart for planning are
1. Determining the requirements for the products and services
2. Establishing criteria for
1. The processes
2. The acceptance of products and services
3. Determining the resources needed to achieve conformity to the
product and service requirements
4. Implementing control of the processes in accordance with the
criteria
5. Determining, maintaining and retaining documented information
to the extent necessary
1. To have confidence that the processes have been carried out as
planned
2. To demonstrate the conformity of products and services to
their requirements
Xxx is control planned changes and reviews the consequences of
unintended changes, taking action to mitigate any adverse effects, as
necessary. Xxx is ensuring that outsourced processes are controlled.
8.2 Requirements for products and services
8.2.1 Customer communication
Communication with customers is include
1. Providing information relating to products and services
2. Handling inquiries, contracts or orders, including changes
3. Obtaining customer feedback relating to products and services,
including customer complaints
4. Handling or controlling customer property
5. Establishing specific requirements for contingency actions, when
relevant
Customers are communicated regarding the product information
through the letter, verbal, and/ or through phone, Fax, e-mail. If any
amendments in inquiries, purchase orders it will be communicated
through Phone, letter & Email. The customer complaints are registered
in the customer complaint register and the corrective action taken is
communicated.
8.2.2 Determining the requirements for products and
services
When determining the requirements for the products and services to
be offered to customers, the Xxx is ensuring that
1. The requirements for the products and services are defined,
including
1. Any applicable statutory and regulatory requirements
2. Those considered necessary by the organization
2. The organization can meet the claims for the products and
services it offers
At present, the marketing activities are looked after by Marketing in
charge and both of them are actively involved in the determination of
customer requirements and for each enquiry, he determines the
 Requirements related to the product in contract review form with
respect to requirements specified by the customer, including the
requirements for delivery and post-delivery activities.
 Requirements not stated by the customer but necessary for specific
or intended use (where Known)
 Statutory and Regulatory requirements related to the product
 Any additional requirements determined by the organization.
8.2.3 Review of the requirements for products and services
8.2.3.1 Xxx is ensuring that it has the ability to meet the
requirements for products and services to be offered to
customers. Xxx is conducting a review before committing to supply
products and services to a customer, to include
1. Requirements specified by the customer, including the
requirements for delivery and post-delivery activities.
2. Requirements not stated by the customer, but necessary for the
specified or intended use, when known.
3. Requirements specified by the organization.
4. Statutory and regulatory requirements applicable to the products
and services.
5. Contract/order requirements differing from those previously
expressed
Xxx is ensuring that contract or order requirements differing from
those previously defined are resolved. The customer’s requirements
are confirmed by Xxx is before acceptance, when the customer does
not provide a documented statement of their requirements
8.2.3.2 Xxx is retain documented information, as applicable
1. On the results of the review
2. On any new requirements for the products and services
 IN CHARGE MKT shall review the requirement related to the
product. This review takes place as and when a new P.O or
verbal order is placed/confirmed by the customer for a new part
no. and prior to the commitment taken to supply the products.
 The review ensures that
1. the product requirements are defined
2. Contract/order requirements differing from those previously
expressed in the proposal or quote are resolved.
3. Our organization has the ability to meet the defined
requirements
8.2.4 Changes to requirements for products and services
Xxx is ensured that relevant documented information is amended,
and those relevant persons are made aware of the changed
requirements when the requirements for products and services are
changed
8.3 Design and development of products and services
8.3.1 General
Xxx is establishing, implement and maintain a design and
development process that is appropriate to ensure the subsequent
provision of products and services.
8.3.2 Design and development planning
Xxx is considering In determining the stages and controls for design
and development, including
1. Nature, duration and complexity of the design and development
activities
2. The required process stages, including application design and
development reviews
3. The required design and development verification and validation
activities
4. The responsibilities and authorities involved in the design and
development process
5. The internal and external resource needs for the design and
development of products and services
6. The need to control interfaces between persons involved in the
design and development process
7. The need for involvement of customers and users in the design and
development process
8. The requirements for the subsequent provision of products and
services
9. The level of control expected for the design and development
process by customers and other relevant interested parties.
10. The documented information needed to demonstrate that design
and development requirements have been met.
8.3.3 Design and development inputs
Xxx determines the requirements essential for the specific types of
products and services to be designed and developed. Xxx is consider
1. Functional and performance requirements
2. Information derived from previous similar design and
development activities
3. Statutory and regulatory requirements
4. Standards or codes of practice that the organization has
committed to implement
5. Potential consequences of failure due to the nature of the
products and services
Inputs shall be adequate for design and development purposes,
complete and unambiguous. Conflicting design and development
inputs is resolved. Xxx is retain documented information on design
and development inputs.
8.3.4 Design and development controls
Xxx is applying controls to the design and development process to
ensure that
1. The results to be achieved are defined
2. Reviews are conducted to evaluate the ability of the results of
design and development to meet requirements,
3. Verification activities are conducted to ensure that the design and
development outputs meet the input requirements.
4. Validation activities are conducted to ensure that the resulting
products and services meet the requirements for the specified
application or intended use,
5. Any necessary actions are taken on problems determined during
the reviews, or verification and validation activities.
6. Documented information of these activities is retained
8.3.5 Design and development outputs
Xxx ensure that design and development outputs
1. meet the input requirements
2. are adequate for the subsequent processes for the provision of
products and services
3. include or reference monitoring and measuring requirements, as
appropriate, and acceptance criteria
4. specify the characteristics of the products and services that are
essential for their intended purpose and their safe and proper
provision
Xxx is retain documented information on design and development
outputs
8.3.6 Design and development changes
Xxx is identifying, review and control changes made during, or
subsequent to, the design and development of products and services,
to the extent necessary to ensure that there is no adverse impact on
conformity to requirements. Xxx is retain documented information
on
1. Design and development changes
2. The results of reviews
3. The authorization of the changes
4. The actions are taken to prevent adverse impacts
8.4 Control of externally provided processes, products and
services (Purchase)
8.4.1 General
Xxx is ensuring that externally provided processes, products and
services conform to requirements, Xxx determines the controls to be
applied to externally provided processes, products and services when
1. Products and services from external providers are intended for
incorporation into the organization’s own products and services
2. Products and services are provided directly to the customer(s) by
external providers on behalf of the organization.
3. A process, or part of a process, is provided by an external
provider as a result of a decision by the organization
Xxx determines and applies criteria for the evaluation, selection,
monitoring of performance, and re-evaluation of external providers,
based on their ability to provide processes or products and services in
accordance with requirements. The organization shall retain
documented information of these activities and any necessary actions
arising from the evaluations.
IN CHARGE Purchase ensures that the purchased products are
procured from Approved sources only and which conforms to
specified purchase requirements. This is done as per the business
process flow for PROCUREMENT. The type and control to be exercised
on the supplier, based on the effect of the purchased product on the
process/final product, is defined in the Approved Supplier List. IN
CHARGE Purchase evaluates and select supplier based on their ability
to supply product in accordance with the requirements of the
organization. Criteria for selection, evaluation, and re-evaluation are
described and depicted in the Business Process Flowchart.
1. Selection, Evaluation and approval of suppliers
2. Periodical evaluation of Supplier
3. Approved Supplier List will be maintained by the IN CHARGE
Purchase and also the records of their periodical performance.
8.4.2 Type and extent of control
Xxx ensures that externally provided processes, products and
services do not adversely affect the organization’s ability to
consistently deliver conforming products and services to its
customers
Xxx is
1. Ensure that externally provided processes remain within the
control of its quality management system
2. Define both the controls that it intends to apply to an external
provider and those it intends to apply to the resulting output
3. Take into consideration
1. The potential impact of the externally provided processes,
products and services on the organization’s ability to
consistently meet customer and applicable statutory and
regulatory requirements
2. The effectiveness of the controls applied by the external
provider
4. Determine the verification, or other activities, necessary to ensure
that the externally provided processes, products and services meet
requirements
8.4.3 Information for external providers
Xxx ensures the adequacy of requirements prior to their
communication to the external provider. Xxx is communicating to
external providers its requirements for
1. The processes, products and services to be provided
2. The approval of
1. Products and services
2. Methods, processes and equipment
3. The release of products and services
1. Competence, including any required qualification of persons
2. The external providers’ interactions with the organization
3. Control and monitoring of the external providers’ performance to
be applied by the organization
4. Verification or validation activities that the organization, or its
customer, intends to perform at the external providers’ premises
The Purchase order describes the product to be purchased including
1. Requirement of Material Test Certificate / Dimensional report /
PPAP such as Control Plan / Process Flow Chart / Process Sheets
/ Process Capability studies etc.
2. Requirements for qualification of personnel
3. QMS requirements.
PO will be reviewed for adequacy of the specified requirement prior to
release by IN CHARGE Purchase & M.R. The Purchase order released
to the supplier indicates the intended verification arrangements and
method of product release, whenever KWS or its customer intends to
perform such verification at external providers end.
Incoming Product Quality
The control / Inspection plan for incoming be based on the control
exercised on the external providers
1. Inspection and/or testing on sampling method. The sampling size
should be decided based on past performance of the supplier.
2. Inspection at Sub-contractor’s premises with/without system
audit.
3. Quality assurance certificate or the test report from the supplier.
4. Part evaluation by accredited laboratories.
5. Receipt and evaluation of statistical data.
6. Any of above method or Combination of any two or more from
above.
Supplier Monitoring
External providers performance monitoring through the following
indicators, & will be carried out by IN CHARGE PUR as described in
Procedure for Purchase.
Delivered Product Quality.
 Delivery Performance.
 Customer disruptions including field Returns.
 Customer notification Related to quality Or delivery Issues
 Premium freight.
Xxx promotes monitoring of the performance of manufacturing
processes of the external providers’ as part of supplier development.
8.5 Production and service provision
8.5.1 Control of production and service provision
Xxx is implemented production and service provision under
controlled conditions. Controlled conditions include, as applicable
1. The availability of documented information that defines
1. The characteristicsof the products to be produced, the
services to be provided, or the activities to be performed
2. The results to be achieved
2. The availability and use of suitable monitoring and measuring
resources
3. The implementation of monitoring and measurement activities at
appropriate stages to verify that criteria for control of processes
or outputs, and acceptance criteria for products and services
have been met
4. The use of suitable infrastructure and environment for the
operation of processes
5. The appointment of competent persons, including any required
qualification
6. The validation, and periodic revalidation, of the ability to achieve
planned results of the processes for production and service
provision, where the resulting output cannot be verified by
subsequent monitoring or measurement;
7. The implementation of actions to prevent human error
8. The implementation of release, delivery and post-delivery
activities
Production In-Charge shall plan the production as per and respective
Section In-charge carry out the process under the controlled condition
as defined in Process Flow in respective process procedures.
Controlled conditions shall include:-
1. Production plans for all processes which describes the
characteristics of the product and process flow chart for the
sequence of operations
2. Work Instructions made available at all workstations.
3. Use of appropriate equipment for a particular process/operation
4. Use of calibrated monitoring and measuring devices
5. In process inspection/verification
6. Verification of acceptance criteria
Production Plan
The production plan for all stages of production, including receipt of
the material sample, pilot & regular production shall be used. These
Production plans at each stage may be amendments of production
plans of the earlier stage. As described above, Marketing shall be
involved in the preparation of production plans where required by
customer production Plans will be submitted to the customer for
approval. The production plan shall
 list the controls used for the manufacturing processes
 Include methods for monitoring of control exercised over special
characteristics defined by both the customer and the
organization.
 Include the customer required information if any
 Initiate the specified reaction plan when the process becomes
unstable or not statistically capable production plans shall be
reviewed and updated, as appropriate:
 The product is changed.
 The manufacturing processes are changed.
 The processes become unstable.
 The processes become non-capable.
 Inspection frequency and method changes
 Change in supply sources
 Corrective actions based on process NC,s & customer concerns
 Drawing changes / ECNs.
Production plans are developed for all the processes involved in the
manufacturing by the Cross-functional team. These are identified
during the advanced product planning process. Wherever
approvable. The production plans are live documents and are
reviewed and updated when the change to the original product or
process occurs.
Work Instructions
Respective IN CHARGE prepares Work Instructions for all
operations/process activities and for all employees having
responsibilities under them. These instructions are made accessible for
use at the work station& are prepared based on trial run result and
old documents of the similar product at the time of job induction into
production and will be reviewed for applicable changes in event of
production Plan change(s).
Preventive Maintenance
IN CHARGE MNT maintains a list of all machines/equipment used in
production and designated key process equipment in the list. A plan
for preventive maintenance for this key equipment shall be developed
& implemented to ensure continuous process capability. This plan
shall be based on the available data from the manufacturer’s
recommendations, previous breakdown and preventive history, the
extent of usage, and rate of wear and tear, etc., based on these details
appropriate predictive techniques are used. IN CHARGE MNT ensures
that required spare-parts for a replacement along with other resources
for maintenance as per preventive maintenance schedule are
available in time. Appropriate records of maintenance shall be
maintained by IN CHARGE MNT. A system that describes the planned
& predictive maintenance method is detailed in Procedure
respectively.
Validation of processes for production and Service Provision
All processes are validated before the start of the production through
set up approval and First Five Piece Inspection. The above processes
are controlled and continually monitored through documented work
instructions, process qualifications, set up approval, and worker
qualification, as applicable to ensure that the specified requirements
are met.
Appropriate records are maintained by All IN CHARGE to
demonstrate the control of these processes and equipment. Records of
personnel qualifications and re-qualifications are maintained by All
IN CHARGE. Stipulate workmanship standards to the greatest
practicable extent, where appropriate, by means of written standards,
representative samples, or display boards.
Ensure Handling, Storing, and transporting within the production
shop are carried to protect all materials/products. The details of
process controls are described in respective department procedures.
8.5.2 Identification and traceability
Xxx is used suitable means to identify outputs when it is necessary to
ensure the conformity of products and services. Xxx has identified the
status of outputs with respect to monitoring and measurement
requirements throughout production and service provision. Xxx is
controlling the unique identification of the outputs when traceability
is a requirement and shall retain the documented information
necessary to enable traceability. All material is identified including
inspection and test status inappropriate manner (paint, punch mark,
labels, stickers, and tagging, etc.) from receipts at stores through
various stages of production. The final product is kept on trolleys &
transferred to the Finished Goods area before delivery to the customer
as detailed in work procedures for storage, packing & dispatch
procedure. Traceability is provided, if required by the customer or
decided for some products by KWS to identify finished products by
providing punch mark/tag/batch code. For such products, proper
records are maintained also the main packages are traceable through
the Barcode system.
8.5.3 Property belonging to customers or external
providers
Xxx is exercise care with property belonging to customers or external
providers while it is under the organization’s control or being used by
the organization
Xxx identify, verify, protect and safeguard customers’ or external
providers’ property provided for use or incorporation into the
products and services
When the property of a customer or external provider is lost, damaged
or otherwise found to be unsuitable for use, the organization shall
report this to the customer or external provider and retain
documented information on what has occurred
 Any arrangement of Customer Supplied raw materials,
components, tooling, returnable packaging, measuring
instruments, etc., are identified during the contract review by
CFT/ IN CHARGE MKT and communicated to the people
concerned.
 All such products are uniquely identified after proper verification
and properly stored and maintained. Any such product that is
lost damaged or is otherwise unsuitable for use shall be recorded
and reported to the Customer by customer representative & IN
CHARGE Marketing.
It shall be the responsibility of QA personnel to verify the quality of
such product even if it has been supplied by the Customer
8.5.4 Preservation
Xxx preserves the outputs during production and service provision, to
the extent necessary to ensure conformity to requirements.
Preservation includes identification, handling, contamination control,
packaging, storage, transmission or transportation, and protection. At
all stages of production, appropriate material/product handling,
storage, packing of products, preservation, and delivery of products
established viz. The material in storage – is preserved by packing in
Gunny bags. In-process – the material is stored in Bins and Air Bubble
bags. Finished goods – All parts are surface coated & packed in BINS
with Plastic coverage.
Storage and Inventory
A suitable inventory control system is established to optimize
inventory turns, assure stock rotation & minimize inventory levels.
Stores Section shall monitor stock levels and inform the purchase
section in time & FIFO is emphasized.
Handling and Storage of Incoming Material
At present manual methods are provided for the movement of brought-
out items and raw material respectively. In charge, Stores shall
ensure safe handling of materials/items received in stores.
Secured storage space with proper environmental conditions to
protect the products stored shall be provided for all items in stores.
Shelf-life items are identified and periodic inspection of all stored
items is conducted once in three months for fitness for use.
Store In-charge has the defined responsibility to receive issue &
dispatch materials from secured storages i.e., Stores & Finished Goods
Stock point.
All material in stock is periodically assessed to verify continued
fitness for use. The proper material accounting shall be maintained
in the stock ledger, with the consideration for keeping stored items in
usable conditions.
In process Products
Handling of In-process material is done using Trollies and BINS. At
all times the individual operator ensures safe handling of the material
to prevent damage. Storage on the shop floor, for in-process products,
if required suitable packaging material will be used to protect the
products from any kind of damages, deterioration due to
environmental conditions.
Finished Products
Finished products are handled carefully with the use of hydraulic
Trollies and packed by using BINS and Polythene bags, so as to protect
them from any kind of damage and kept in Finished goods area is the
duly cleaned condition. All finished products stored will be under the
control of the assembly in charge.
Packaging
The packaging of products carried out according to packaging
instructions/drawings wherever applicable, i.e., contractually agreed
or if product nature calls for packing. Type of packaging material &
its quality is ensured as per customer requirements if mentioned in the
purchase order. Material/packages used for the packing of products
are verified before packing to ensure its conformance to specified
requirements as per Purchase Order/ Customer Requirement. The
packing method employed will be adequate to protect the products
fully till they reach their destination if contractually specified.
8.5.5 Post-delivery activities
Xxx is meet requirements for post-delivery activities associated with
the products and services
Xxx considers In determining the extent of post-delivery activities
that are required,
1. statutory and regulatory requirements
2. the potential undesired consequences associated with its products
and services
3. nature, use and intended lifetime of its products and services
4. customer requirements
5. customer feedback
Delivery
The product quality is protected after final inspection & testing and
wherever contractually specified extended from delivery to
destination. The deliveries of products are done as per contract
terms/delivery schedules for the customer.
8.5.6 Control of changes
Xxx is review and control changes for production or service
provision, to the extent necessary to ensure continuing conformity
with requirements. Xxx is to retain documented information
describing the results of the review of changes, the person(s)
authorizing the change, and any necessary actions arising from the
review.
8.6 Release of products and services
Xxx implement planned arrangements, at appropriate stages, to
verify that the product and service requirements have been met. The
release of products and services to the customer shall not proceed until
the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and, as applicable, by the
customer.
Xxx is retain documented information on the release of products and
services. The documented information includes
1. Evidence of conformity with the acceptance criteria
2. Traceability to the person(s) authorizing the release
To ensure that the products manufactured meet the quality
requirements of customer fully, a systematic approach for inspection
and testing at all stage viz. incoming, in the process and final are
demonstrated. At each stage, the activity is performed according to
documented procedures.
Receiving Inspection & Testing
Inspection / Verificationof incoming material is carried out according
to the respective Incoming Inspection Standards & Control plans. This
is the responsibility of IN CHARGE QA. The control plan for incoming
shall use one of the following methods –
 Inspection and/or testing on sampling method.
 Inspection at suppliers premises with/without system audit.
 Quality assurance certificate or the test report from the supplier.
The incoming materials used in production shall not be used or
processed without acceptance by Receipt inspection. Store Personnel
are responsible for receipt, identification, records and storage of all
Incoming materials, the detailed procedure for incoming material
inspection is described.
In-process Inspection & Testing
All in-process inspections carried out according to the applicable
control plans by QA during in process based on sample inspection and
as per the documented procedures for the required tests. The details of
in-process inspection are described in the respective process owner’s
procedure Inspection and Tests Records
Records of inspection/tests at all stages mentioned above are
prepared in specific forms & maintained. The format-number(s) of
records as mentioned in respective procedures/work instructions
/control plans. IN CHARGE QA & IN CHARGE PRD will be the
approving authority at each stage for the disposition of non-
conforming materials/products. The system of handling of non-
conforming materials/products is described in
8.7 Control of nonconforming outputs
Procedures are established for identifying non-conforming product
at Stores and stages of production/inspection as well as at the final
inspection stage. The non-conforming materials are identified by the
production operator/ QA Personnel at these stages and suitably
identified. Responsibility and authority are assigned for segregation,
review and disposition of non-conforming product. Documented
information of segregation, review and suitable disposition of non-
conforming materials are maintained by QA Personnel. Who is
authorized to review the non-conforming product?
The decisions of review as per application for disposition may be
 The action which has to be taken to eliminate the non-conforming
situation.
 Use as it is under concessions (deviation) / with partial rework or
without rework after approval from defined Authorization.
 Rework to meet specifications.
 Reject / scrap.
 Return to the supplier.
 Regard for alternative applications.
 Reworked / Repaired product re-verified to demonstrate
conformity to the requirement in accordance with the documented
control plan. Details for the handling of nonconforming outputs
are described in Procedure
9 Performance evaluations
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
Xxx is evaluating the performance and the effectiveness of the quality
management system. Xxx is retaining appropriate documented
information as evidence of the results.
Purpose: To establish measurement, analysis and improvement
plan for all the process / Function defined in the Quality
Management System.
Objective: To establish quality management measurement process
and monitor as per planned results for achievement also establish
processes to identify non-conformity situation and subsequently
corrective & preventive actions to be taken. IN CHARGE QA in
consultation with all respective production process heads plan and
implement the monitoring, measurement, analysis, and improvement
processes needed.
1. What needs to be monitored and measured
2. The methods for monitoring, measurement, analysis and
evaluation needed to ensure valid results
3. When the monitoring and measuring shall be performed
4. When the results from monitoring and measurement are analysed
and evaluated
9.1.2 Customer satisfaction
Xxx is to monitor customers’ perceptions of the degree to
which their needs and expectations have been fulfilled.
Xxx is determined the methods for obtaining, monitoring,
and reviewing this information. The MKT In Charge has
primary responsibility for Customer Satisfaction as one of
the measurements of the Quality Management System and
as to whether the organization has met customer
requirements. Customer satisfaction shall include the
collection of authentic data, frequency, and validity of the
analysis. The trend and major elements affecting customer
satisfaction and key indicators of customer dissatisfaction
will be monitored supported by objective evidence.
Wherever data available, the level of customer satisfaction
will be compared with those of our competitors & a relevant
action plan will be evolved. A customer satisfaction analysis
survey will be conducted ONCE IN A 12 MONTHS Review of
customer satisfaction will be taken by top management
during Management Review Meeting as described in
Procedure.
9.1.3 Analysis and evaluation
Xxx is analyzed and evaluates appropriate data and information
arising from monitoring and measurement. The results of the analysis
are used to evaluate
1. Conformity of products and services
2. The degree of customer satisfaction;
3. The performance and effectiveness of the quality management
system;
4. If planning has been implemented effectively;
5. The effectiveness of actions taken to address risks and
opportunities;
6. The performance of external providers;
7. The need for improvements to the quality management system
9.2 Internal audit
Procedures are established for a system of planned and documented
internal quality audits to verify that the Quality Management System
conforms to the planned arrangements as per ISO 9001:2015
requirements and effectively implemented and maintained.
The MR is responsible for:
 Planning and organizing audits at works depending on the
importance and the extent of the activity concerned and the
results of the previous audits. The internal quality system audits
as per schedule are to be carried out at least once in SIX
Months period and at least 02 times during a year.
 MR also ensures that the trained auditors are involved in quality
system audit to ensure the objectivity of the auditing processes
and are not directly responsible for the area under audit. The
results of the audit are documented in the specified format to
record non-conformances in product/process and work practices
and brought to the notice of the person responsible for the area
audited, who in turn shall take appropriate corrective actions
within the agreed time limit and ensure removal of deficiencies
observed. Follow up on the effectiveness of the corrective action
taken.
 The effectiveness of identified corrective action against any such
internal audit findings is verified by the MR prior to subsequent
management review meetings and recorded.
 MR is responsible for ensuring that non-conformances observed
during IA are closed by appropriate corrective action
implementation in a defined period.MR identifies and marks the
corrective actions needing confirmation for their effective
implementation and also arranges for the verification in
subsequent audits or follow-up audits will be planned.
 MR maintains appropriate records of implementation &
effectiveness in the form of internal audit reports. The details of
the audit team, schedule, preparation of non-conformances
reports,
 The follow up on the corrective actions is detailed in the procedure
for corrective action
 The nonconformance identified during third-party audits or by
external agencies is handled in the same manner. The non-
conformances of IA remaining open due to a delay in the
implementation of corrective action along with major non-
conformances recorded will be reviewed during management
review meetings.
9.3 Management review
9.3.1 General
Top management of Xxx is reviewing the organization’s quality
management system, at planned intervals, to ensure its continuing
suitability, adequacy, effectiveness, and alignment with the strategic
direction of the organization. Management review will be conducted
and chaired by MD once in SIX Months to ensure continuing
suitability & effectiveness in satisfying the requirements of ISO
9001:2015 and the stated quality policy and objectives.
The Management Review will include all elements of the entire quality
system as detailed in the procedure and schedule for the Management
Review. Records of Management Review Meetings shall be
maintained by MR. The Director during review shall assess
opportunities for improvement and the need for changes in the Quality
Management System, including the Quality Policy and Quality
Objectives.
9.3.2 Management review inputs
The management review is planned and carried out taking into
consideration
1. The status of actions from previous management reviews
2. Changes in external and internal issues that are relevant to the
quality management system;
3. Information on the performance and effectiveness of the quality
management system, including trends in:
 customer satisfaction and feedback from relevant interested
parties;
 the extent to which quality objectives have been met;
 process performance and conformity of products and services;
 nonconformities and corrective actions;
 monitoring and measurement results;
 audit results;
 the performance of external providers
4. The adequacy of resources;
5. The effectiveness of actions taken to address risks and
opportunities;
6. Opportunities for improvement
9.3.3 Management review outputs
The outputs of the management review shall include decisions and
actions related to:
1. Opportunities for improvement;
2. Any need for changes to the quality management system;
3. Resource needs.
The Xxx is retain documented information as evidence of the results
of management reviews
10 Improvement
10.1 General
Xxx determines and select opportunities for improvement and
implement any necessary actions to meet customer requirements and
enhance customer satisfaction. These include
1. Improving products and services to meet requirements as well as
to address future needs and expectations.
2. Correcting, preventing or reducing undesired effects;
3. Improving the performance and effectiveness of the quality
management system.
Improvement is included correction, corrective action, continual
improvement, breakthrough change, innovation, and re-
organization.
10.2 Nonconformity and corrective action
10.2.1 When nonconformity occurs, including any arising from
complaints, Xxx is
 All nonconformities relating to product, process and quality
system are investigated & the results are recorded. While
investigating the causes of non-conformances & deciding
corrective actions, the team identifies other products/situations
where same or similar nonconformance can occur.
 Corrective actions for nonconforming products and processes,
detected in the organization are recorded; analyzed, reviewed and
necessary actions are taken. This will be the responsibility of IN
CHARGE QA & PRD (respective production process In-charge) the
corrective action and preventive measures are implemented and
their effectiveness is monitored.
The details are as described in the procedure. Corrective actions are
taken on customer complaints; by analyzing the causes of the
complaints and taking suitable action to prevent their reoccurrence.
The effectiveness of the identified corrective action is monitored
through customer feedback and also the customers are kept aware of
the corrective actions initiated, with each identified corrective action.
10.3 Continual improvement
Xxx continually improved the suitability, adequacy, and effectiveness
of the quality management system. Xxx considers the results of
analysis and evaluation, and the outputs from management review,
to determine if there are needs or opportunities that shall be addressed
as part of the continual improvement

More Related Content

What's hot

Qms kick off meeting ppt
Qms kick off meeting pptQms kick off meeting ppt
Qms kick off meeting pptANUPAM RAY
 
Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides SlideTeam
 
Audit iso 9001-2015-checklist-
Audit iso 9001-2015-checklist-Audit iso 9001-2015-checklist-
Audit iso 9001-2015-checklist-Anand Vedpathak
 
Qms awareness training
Qms awareness trainingQms awareness training
Qms awareness trainingshree
 
A brief Introduction to ISO 9001 2015-Quality Management System
A brief Introduction to ISO 9001 2015-Quality Management SystemA brief Introduction to ISO 9001 2015-Quality Management System
A brief Introduction to ISO 9001 2015-Quality Management SystemSARWAR SALAM
 
Iso 9001 2015 audit checklist
Iso 9001 2015 audit checklistIso 9001 2015 audit checklist
Iso 9001 2015 audit checklistHamid Ali
 
ISO 9001:2000 Audit Checklist2000
ISO 9001:2000 Audit Checklist2000ISO 9001:2000 Audit Checklist2000
ISO 9001:2000 Audit Checklist2000Dan Junkins
 
Awareness of qms
Awareness of qmsAwareness of qms
Awareness of qmsalabs
 
ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation Govind Ramu
 
Quality Management System awareness for all
Quality Management System awareness for all Quality Management System awareness for all
Quality Management System awareness for all ANUPAM RAY
 
ISO 9001:2015 Introduction & Awareness Training
ISO  9001:2015 Introduction & Awareness Training ISO  9001:2015 Introduction & Awareness Training
ISO 9001:2015 Introduction & Awareness Training Sadanand Borade
 
Introduction to ISO 9001-2008
Introduction to ISO 9001-2008Introduction to ISO 9001-2008
Introduction to ISO 9001-2008AD Sarwar
 
Quality management systems
Quality management systemsQuality management systems
Quality management systemsQaisar Mehmud
 

What's hot (20)

Qms kick off meeting ppt
Qms kick off meeting pptQms kick off meeting ppt
Qms kick off meeting ppt
 
ISO 9001:2015
ISO 9001:2015ISO 9001:2015
ISO 9001:2015
 
Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides Quality Management System PowerPoint Presentation Slides
Quality Management System PowerPoint Presentation Slides
 
Audit iso 9001-2015-checklist-
Audit iso 9001-2015-checklist-Audit iso 9001-2015-checklist-
Audit iso 9001-2015-checklist-
 
Qms awareness training
Qms awareness trainingQms awareness training
Qms awareness training
 
The new ISO 9001:2015
The new ISO 9001:2015The new ISO 9001:2015
The new ISO 9001:2015
 
A brief Introduction to ISO 9001 2015-Quality Management System
A brief Introduction to ISO 9001 2015-Quality Management SystemA brief Introduction to ISO 9001 2015-Quality Management System
A brief Introduction to ISO 9001 2015-Quality Management System
 
Iso 9001 2015
Iso 9001 2015 Iso 9001 2015
Iso 9001 2015
 
Iso 9001 2015 audit checklist
Iso 9001 2015 audit checklistIso 9001 2015 audit checklist
Iso 9001 2015 audit checklist
 
ISO 9001:2000 Audit Checklist2000
ISO 9001:2000 Audit Checklist2000ISO 9001:2000 Audit Checklist2000
ISO 9001:2000 Audit Checklist2000
 
Awareness of qms
Awareness of qmsAwareness of qms
Awareness of qms
 
ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation ISO 9001 2015 Overview presentation
ISO 9001 2015 Overview presentation
 
QMS Awareness Session
QMS Awareness SessionQMS Awareness Session
QMS Awareness Session
 
Quality Management System awareness for all
Quality Management System awareness for all Quality Management System awareness for all
Quality Management System awareness for all
 
ISO 9001:2015 Introduction & Awareness Training
ISO  9001:2015 Introduction & Awareness Training ISO  9001:2015 Introduction & Awareness Training
ISO 9001:2015 Introduction & Awareness Training
 
9001-2015
9001-20159001-2015
9001-2015
 
SQMC briefing on ISO 9001 2015
SQMC briefing on ISO 9001 2015SQMC briefing on ISO 9001 2015
SQMC briefing on ISO 9001 2015
 
Quality Policy
Quality PolicyQuality Policy
Quality Policy
 
Introduction to ISO 9001-2008
Introduction to ISO 9001-2008Introduction to ISO 9001-2008
Introduction to ISO 9001-2008
 
Quality management systems
Quality management systemsQuality management systems
Quality management systems
 

Similar to Example of quality manual

04aiso9001 2015checklist-170302031337
04aiso9001 2015checklist-17030203133704aiso9001 2015checklist-170302031337
04aiso9001 2015checklist-170302031337Sunil Arora
 
04 a iso 9001 2015 checklist
04 a iso 9001 2015 checklist04 a iso 9001 2015 checklist
04 a iso 9001 2015 checklistSon Pham
 
Internal Audit Checklist ISO9001-2015.docx
Internal Audit Checklist ISO9001-2015.docxInternal Audit Checklist ISO9001-2015.docx
Internal Audit Checklist ISO9001-2015.docxSTACATALINAMARLON
 
ISO 9001:2015 Awareness course
ISO 9001:2015 Awareness courseISO 9001:2015 Awareness course
ISO 9001:2015 Awareness courseAerospace Chapter
 
Internal auditchecklistiso9001 2015
Internal auditchecklistiso9001 2015Internal auditchecklistiso9001 2015
Internal auditchecklistiso9001 2015Dinesh Kumar
 
ISO 9001:2015 Transition Key Changes and Issues Webinar
ISO 9001:2015 Transition Key Changes and Issues WebinarISO 9001:2015 Transition Key Changes and Issues Webinar
ISO 9001:2015 Transition Key Changes and Issues WebinarColin Gray
 
30-9(ISO9001-2015).pptx
30-9(ISO9001-2015).pptx30-9(ISO9001-2015).pptx
30-9(ISO9001-2015).pptxibr1722011
 
39635837 iso-9001-2008-awarness
39635837 iso-9001-2008-awarness39635837 iso-9001-2008-awarness
39635837 iso-9001-2008-awarnesssride01
 
ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES
ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES
ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES ParmiGajjar
 
✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?
✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?
✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?sistemaCertification
 
Role of Top management
Role of Top managementRole of Top management
Role of Top managementHpm India
 
Quality management services sustainability training
Quality management services sustainability trainingQuality management services sustainability training
Quality management services sustainability trainingCarlo Magno
 
Basic concepts of Total Quality Management
Basic concepts of Total Quality ManagementBasic concepts of Total Quality Management
Basic concepts of Total Quality Managementmangadynasty5
 
BS 99001 Quality Management in the Built Environment sector.pdf
BS 99001 Quality Management in the Built Environment sector.pdfBS 99001 Quality Management in the Built Environment sector.pdf
BS 99001 Quality Management in the Built Environment sector.pdfdemingcertificationa
 
Iso 90012015 checklist-tcm14-57745
Iso 90012015 checklist-tcm14-57745Iso 90012015 checklist-tcm14-57745
Iso 90012015 checklist-tcm14-57745Suhail P.M.
 
_Audit_Questionnaire_ISO9001_EN_.docx
_Audit_Questionnaire_ISO9001_EN_.docx_Audit_Questionnaire_ISO9001_EN_.docx
_Audit_Questionnaire_ISO9001_EN_.docxAhmedMogawer1
 
Iso Process Audit Training
Iso Process Audit TrainingIso Process Audit Training
Iso Process Audit Trainingsrmortensen
 

Similar to Example of quality manual (20)

04aiso9001 2015checklist-170302031337
04aiso9001 2015checklist-17030203133704aiso9001 2015checklist-170302031337
04aiso9001 2015checklist-170302031337
 
04 a iso 9001 2015 checklist
04 a iso 9001 2015 checklist04 a iso 9001 2015 checklist
04 a iso 9001 2015 checklist
 
Internal Audit Checklist ISO9001-2015.docx
Internal Audit Checklist ISO9001-2015.docxInternal Audit Checklist ISO9001-2015.docx
Internal Audit Checklist ISO9001-2015.docx
 
Iso 9001
Iso 9001Iso 9001
Iso 9001
 
ISO 9001:2015 Requirements.pptx
ISO 9001:2015 Requirements.pptxISO 9001:2015 Requirements.pptx
ISO 9001:2015 Requirements.pptx
 
ISO 9001:2015 Awareness course
ISO 9001:2015 Awareness courseISO 9001:2015 Awareness course
ISO 9001:2015 Awareness course
 
Internal auditchecklistiso9001 2015
Internal auditchecklistiso9001 2015Internal auditchecklistiso9001 2015
Internal auditchecklistiso9001 2015
 
ISO 9001:2015 Transition Key Changes and Issues Webinar
ISO 9001:2015 Transition Key Changes and Issues WebinarISO 9001:2015 Transition Key Changes and Issues Webinar
ISO 9001:2015 Transition Key Changes and Issues Webinar
 
30-9(ISO9001-2015).pptx
30-9(ISO9001-2015).pptx30-9(ISO9001-2015).pptx
30-9(ISO9001-2015).pptx
 
39635837 iso-9001-2008-awarness
39635837 iso-9001-2008-awarness39635837 iso-9001-2008-awarness
39635837 iso-9001-2008-awarness
 
ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES
ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES
ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES
 
total+quality+management
total+quality+management total+quality+management
total+quality+management
 
✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?
✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?
✅ WHY IS ISO 20000-1 CERTIFICATION A GOOD IDEA FOR YOUR ORGANIZATION GROWTH?
 
Role of Top management
Role of Top managementRole of Top management
Role of Top management
 
Quality management services sustainability training
Quality management services sustainability trainingQuality management services sustainability training
Quality management services sustainability training
 
Basic concepts of Total Quality Management
Basic concepts of Total Quality ManagementBasic concepts of Total Quality Management
Basic concepts of Total Quality Management
 
BS 99001 Quality Management in the Built Environment sector.pdf
BS 99001 Quality Management in the Built Environment sector.pdfBS 99001 Quality Management in the Built Environment sector.pdf
BS 99001 Quality Management in the Built Environment sector.pdf
 
Iso 90012015 checklist-tcm14-57745
Iso 90012015 checklist-tcm14-57745Iso 90012015 checklist-tcm14-57745
Iso 90012015 checklist-tcm14-57745
 
_Audit_Questionnaire_ISO9001_EN_.docx
_Audit_Questionnaire_ISO9001_EN_.docx_Audit_Questionnaire_ISO9001_EN_.docx
_Audit_Questionnaire_ISO9001_EN_.docx
 
Iso Process Audit Training
Iso Process Audit TrainingIso Process Audit Training
Iso Process Audit Training
 

Recently uploaded

reStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdf
reStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdfreStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdf
reStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdfKen Fuller
 
一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证
一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证
一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证epodumf6
 
CFO_SB_Career History_Multi Sector Experience
CFO_SB_Career History_Multi Sector ExperienceCFO_SB_Career History_Multi Sector Experience
CFO_SB_Career History_Multi Sector ExperienceSanjay Bokadia
 
Call Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance BookingCall Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance Bookingroncy bisnoi
 
Dubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big Boody
Dubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big BoodyDubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big Boody
Dubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big Boodykojalkojal131
 
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
 
Dark Dubai Call Girls O525547819 Skin Call Girls Dubai
Dark Dubai Call Girls O525547819 Skin Call Girls DubaiDark Dubai Call Girls O525547819 Skin Call Girls Dubai
Dark Dubai Call Girls O525547819 Skin Call Girls Dubaikojalkojal131
 
Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...
Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...
Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...ssifa0344
 
Personal Brand Exploration ppt.- Ronnie Jones
Personal Brand  Exploration ppt.- Ronnie JonesPersonal Brand  Exploration ppt.- Ronnie Jones
Personal Brand Exploration ppt.- Ronnie Jonesjonesyde302
 
Booking open Available Pune Call Girls Ambegaon Khurd 6297143586 Call Hot In...
Booking open Available Pune Call Girls Ambegaon Khurd  6297143586 Call Hot In...Booking open Available Pune Call Girls Ambegaon Khurd  6297143586 Call Hot In...
Booking open Available Pune Call Girls Ambegaon Khurd 6297143586 Call Hot In...Call Girls in Nagpur High Profile
 
Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...
Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...
Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...amitlee9823
 
Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...
Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...
Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...Pooja Nehwal
 
Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...
Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...
Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...amitlee9823
 
Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...
Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...
Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...amitlee9823
 
Dubai Call Girls Starlet O525547819 Call Girls Dubai Showen Dating
Dubai Call Girls Starlet O525547819 Call Girls Dubai Showen DatingDubai Call Girls Starlet O525547819 Call Girls Dubai Showen Dating
Dubai Call Girls Starlet O525547819 Call Girls Dubai Showen Datingkojalkojal131
 
Internship Report].pdf iiwmoosmsosmshkssmk
Internship Report].pdf iiwmoosmsosmshkssmkInternship Report].pdf iiwmoosmsosmshkssmk
Internship Report].pdf iiwmoosmsosmshkssmkSujalTamhane
 
Miletti Gabriela_Vision Plan for artist Jahzel.pdf
Miletti Gabriela_Vision Plan for artist Jahzel.pdfMiletti Gabriela_Vision Plan for artist Jahzel.pdf
Miletti Gabriela_Vision Plan for artist Jahzel.pdfGabrielaMiletti
 
WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)
WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)
WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)Delhi Call girls
 
Call Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service Bangalore
Call Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service BangaloreCall Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service Bangalore
Call Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service Bangaloreamitlee9823
 
Top Rated Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...
Top Rated  Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...Top Rated  Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...
Top Rated Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...Call Girls in Nagpur High Profile
 

Recently uploaded (20)

reStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdf
reStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdfreStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdf
reStartEvents 5:9 DC metro & Beyond V-Career Fair Employer Directory.pdf
 
一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证
一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证
一比一原版(毕业证书)意大利米兰理工大学毕业证学位证可查学历认证
 
CFO_SB_Career History_Multi Sector Experience
CFO_SB_Career History_Multi Sector ExperienceCFO_SB_Career History_Multi Sector Experience
CFO_SB_Career History_Multi Sector Experience
 
Call Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance BookingCall Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance Booking
Call Girls Alandi Road Call Me 7737669865 Budget Friendly No Advance Booking
 
Dubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big Boody
Dubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big BoodyDubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big Boody
Dubai Call Girls Demons O525547819 Call Girls IN DUbai Natural Big Boody
 
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...
 
Dark Dubai Call Girls O525547819 Skin Call Girls Dubai
Dark Dubai Call Girls O525547819 Skin Call Girls DubaiDark Dubai Call Girls O525547819 Skin Call Girls Dubai
Dark Dubai Call Girls O525547819 Skin Call Girls Dubai
 
Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...
Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...
Solution Manual for First Course in Abstract Algebra A, 8th Edition by John B...
 
Personal Brand Exploration ppt.- Ronnie Jones
Personal Brand  Exploration ppt.- Ronnie JonesPersonal Brand  Exploration ppt.- Ronnie Jones
Personal Brand Exploration ppt.- Ronnie Jones
 
Booking open Available Pune Call Girls Ambegaon Khurd 6297143586 Call Hot In...
Booking open Available Pune Call Girls Ambegaon Khurd  6297143586 Call Hot In...Booking open Available Pune Call Girls Ambegaon Khurd  6297143586 Call Hot In...
Booking open Available Pune Call Girls Ambegaon Khurd 6297143586 Call Hot In...
 
Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...
Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...
Call Girls Devanahalli Just Call 👗 7737669865 👗 Top Class Call Girl Service B...
 
Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...
Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...
Dombivli Call Girls, 9892124323, Kharghar Call Girls, chembur Call Girls, Vas...
 
Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...
Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...
Call Girls Btm Layout Just Call 👗 7737669865 👗 Top Class Call Girl Service Ba...
 
Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...
Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...
Nagavara Call Girls: 🍓 7737669865 🍓 High Profile Model Escorts | Bangalore Es...
 
Dubai Call Girls Starlet O525547819 Call Girls Dubai Showen Dating
Dubai Call Girls Starlet O525547819 Call Girls Dubai Showen DatingDubai Call Girls Starlet O525547819 Call Girls Dubai Showen Dating
Dubai Call Girls Starlet O525547819 Call Girls Dubai Showen Dating
 
Internship Report].pdf iiwmoosmsosmshkssmk
Internship Report].pdf iiwmoosmsosmshkssmkInternship Report].pdf iiwmoosmsosmshkssmk
Internship Report].pdf iiwmoosmsosmshkssmk
 
Miletti Gabriela_Vision Plan for artist Jahzel.pdf
Miletti Gabriela_Vision Plan for artist Jahzel.pdfMiletti Gabriela_Vision Plan for artist Jahzel.pdf
Miletti Gabriela_Vision Plan for artist Jahzel.pdf
 
WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)
WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)
WhatsApp 📞 8448380779 ✅Call Girls In Salarpur Sector 81 ( Noida)
 
Call Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service Bangalore
Call Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service BangaloreCall Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service Bangalore
Call Girls Hoodi Just Call 👗 7737669865 👗 Top Class Call Girl Service Bangalore
 
Top Rated Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...
Top Rated  Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...Top Rated  Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...
Top Rated Pune Call Girls Warje ⟟ 6297143586 ⟟ Call Me For Genuine Sex Servi...
 

Example of quality manual

  • 1. Example of Quality Manual 1.0 Company Profile Include your company profile 1.1 The mission of the Firm Our mission is to enhance mobility through innovation, leadership, and public service. Innovation by providing unparalleled value combined with flexibility and risk-taking ability, leadership by delivering exceptional performance in every domain, and corporate responsibility through service to society. 1.2 The vision of the Firm To strive relentlessly with an aim to achieve excellence in all businesses that we venture into, with the objective of becoming an organization that all its employees and associates are proud of. 2.0 Organization Scope Design, Development of Land, Construction Sales of Residential and Commercial Complexes 2.1 Exclusions: NIL 2.1 Quality Policy XXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectations of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts
  • 2. for enhancement in customer satisfaction while assuring 100% quality and quantity. 2.2 Key Objectives  Timely completion of projects  Increase Customer satisfaction  Reduce Customer Complaint 3.0 Glossary & Abbreviations Sr.No. Abbreviation Description Sr. No. Abbreviation Description 1 XXX Name of Company 18 ASL Approved supplier list 2 QSM Quality System Manual 19 PDIR Pre Despatch Inspection Re 3 DI Documented Information 20 MME Measuring & Monitoring Equipments 4 CFT Cross-Functional Team 21 ISO International Organizationa Standardization 5 CH Chart 22 MKT Marketing 6 CP Control Plan 23 QA Quality Assurance 7 FG Finished Goods 24 PUR Purchase 8 QF Quality Format 25 STR Stores
  • 3. 9 SYS System 26 PRD Production 10 IA Internal Audit 27 HR Human Resource 11 List List 28 MNT Maintenance 12 NC Non Conformance 29 DD Design and Development 13 CA Corrective action 30 LOI Letter of Indent 14 OK Organizational Knowledge 31 MI Measurement traceability 15 NCP Non-Conforming Product 32 PI Performance evaluation 16 NCR Non Conformance Report 33 MRM Management review meeting 17 EP External provider 34 IP Interested Parties 4.0 Context of Organization 4.1 Understanding the organization and its context: Shah Promoters and Developers determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system through PEST and SWOT. The external and internal issues identified through PEST and SWOT are continuously being monitored and reviewed by the CEO. PEST
  • 4. Political Factors (P) 1. Political direction on Smart Cities 2. Allocation for Infrastructure 3. Skill enhancement in Automation Sector 4. Monetary policies Economic Factors (E) 1. The growth of banks in rural areas 2. Funding for smart cities 3. Increase in car park density 4. High GDP growth Social Factors (S) 1. Increased literacy 2. Technological awareness 3. Banking on banks 4. Increased per capita income Technology Factors (T) 1. Advancement in chip design 2. Automation tools growth 3. High technology at low cost 4. Digital technology growth SWOT Strength (S) 1. Strong technology backup 2. Young and motivated team 3. Nil borrowing 4. Quick decision making 5. Strong customer focus Weakness 1. Very small team 2. Lack of experience 3. Weak marketing 4. High inventory 5. Limited customer base Opportunity (O) 1. Lean organization leads to 1. Flexibility in products 2. Quick response to customer needs Threat (T) 1. High technology imports 2. Skill development velocity 3. Increased competition 4. Technology leakage
  • 5. 2. Low level of competition 3. High growth potential 5. Attrition 4.2- Understanding the needs and expectations of interested parties xxx has determined the interested parties who are relevant to the xxx Quality management system and the requirement of the interested parties in order to prevent the potential effect on the organization’s ability to consistently provide products and services which meet the customer and applicable statutory and regulatory requirements. Interested parties Requirements Monitoring & Review mechani External providers 1. Specification communication 2. Payment as agreed 3. On time Supply of Input material (if any) 4. Technology support 1. Defined in the Documented information of External providers control 2. Review in Management rev meetings Customer 1. Quality of product & Service 2. Delivery of product on time 3. Response to complaint 4. Proper Communication channel 1. Defined in the documented information of Marketing & Sales process 2. Review in Management rev meetings Statutory & Regulatory Body Complying with the statutory and regulatory requirements as defined from time to time. 1. Defined in the documented information of Leadership 2. Review in Management rev meetings Bankers / Financiers Updating of changes in the organization whenever it happened Review in Management review meetings Employees Management Support, Payments on time Accounting Control of managem
  • 6. 4.3 Determining the scope of the quality management system The organization had determined the scope of the Quality management system by considering external and internal issues, the requirement of relevant interested parties and Product & Service of the organization. The scope of Quality Management System is Design, Development of Land, Construction Sales of Residential and Commercial Complexes Exclusions: NIL 4.4 Quality management system and its processes 4.4.1: xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes. xxx has determined the inputs required and the outputs expected from each process in an individual process map addressed in the documented information of each process. xxx has determined the sequence and interaction of the processes in Process map & Interactions of processes. xxx has determined and applied the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes in the documented information of each process. xxx has determined the resources needed for these processes and ensures their availability in the documented information of the Support process. xxx has assigned the responsibilities and authorities for each process xxx has addressed the risks and opportunities
  • 7. xxx has been evaluating these processes and implementing any changes needed to ensure that these processes achieve their intended results and improve the processes and the quality management system Improve the processes and the quality management system 4.4.2- xxx is also maintaining documented information to support the operation of its processes and retaining documented information to have confidence that the processes are being carried out as planned. 5.0 Leadership 5.1 Leadership and commitment Xxx Management has demonstrated leadership and commitment with respect to the quality management system through 1. Taking accountability for the effectiveness of the quality management system by periodical review of quality management system through management review meeting, Quality objectives review and providing necessary resources. 2. Management has established the quality policy and quality objectives for the quality management system and is compatible with the context and strategic direction of the organization. 3. Management has determined the organizational processes and integrated with the quality management system requirement through process map & Interaction this can be demonstrated. 4. The established procedure for promoting the use of the process approach and risk-based thinking. 5. Ensuring that the resources needed for the quality management system are available, this is being periodically reviewed through management review meeting. 6. Communicating the importance of effective quality management and of conforming to the quality management system requirements 7. Ensuring that the quality management system achieves its intended results 8. Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing training, conducting awareness programs and
  • 8. 9. Promoting improvement by introducing the suggestion scheme, Kaizens and conducting meetings. 10. Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. 5.1.2 Customer focus Xxx management has demonstrated leadership and commitment with respect to customer focus by ensuring that: 1. Customer and applicable statutory and regulatory requirements are determined, understood and consistently met. 2. The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed c) The focus on enhancing customer satisfaction is maintained and procedure for customer satisfaction is addressed 5.2 QUALITY POLICY XXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectations of our customers. We promise our valued customer’s commitment to excellence in each activityby each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity. We are also committed to serving society as a whole by generating through a clean development mechanism (CDM) project. 5.2.1 Establishing the quality policy Xxx management has established, implemented and maintained a quality policy that: 1. is appropriate to the purpose and context of the organization and supports its strategic direction. 2. Provides a framework for setting quality objectives 3. Includes a commitment to satisfy applicable requirements
  • 9. 4. Includes a commitment to continual improvement of the quality management system 5.2.2 Communicating the quality policy The quality policy is 1. Available and be maintained as documented information 2. Communicated, understood, and applied within the organization through the display, Training, and periodical review. 3. Available to relevant interested parties, as appropriate. 5.3 Organizational roles, responsibilities and authorities Xxx management has ensured that the responsibilities and authorities for relevant roles are assigned communicated and understood within the organization. While assigning roles, responsibility, and authority, top management has considered and ensured that 1. The quality management system conforms to the requirements of this International Standard 2. The processes are delivering their intended outputs 3. Reporting on the performance of the quality management system and on opportunities for improvement, in particular, to top management 4. The promotion of customer focus throughout the organization 5. The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Roles, responsibility and authorities assigned are available in process & as per Organization chart wise Directors Responsibility  Overall Responsibility for formulating and communicating Quality Policy & Quality objectives.  Formulation of Strategy for continuous up gradation of Business and Quality System.
  • 10.  Ensure periodic assessment of the performance of Quality System.  Approval of Quality System Manual.  Budget Approval for the organization.  Overall Responsibility for Business Development & all financial issues.  Provision of resources as required.  Strategic decisions on developments and technical setups.  To provide the leadership for efficient implementations of the system. Authorities:  Approval of customers orders, P.O. and Cheque.  Sanctioning leaves of all Staff.  Approval of funds for Training needs.  All the authorities of downline personnel.  Chairing Management review meetings. Project Planning Responsibilities:  Overall coordination between client, project managers and office department.  Follow up for Schedules.  The entire responsibility of Quality.  Monitoring Client Satisfaction.  Coordination with the consultants.  Disciplinary actions against the staff.  Prime responsibility for the safety at the site  Provision of a suitable working environment  Ensure the quality system is established, implemented and maintained. Authorities:  Appointment of the staff, engineers and tech staff.
  • 11.  Sanctioning the Leaves to Staff.  All the authorities of downline personnel. Project Managers Responsibilities:  Responsibilities for the entire Project work, i.e. Quality, Quantity and Time.  Coordination with consultants and contractors.  Coordination with Consultants for drawings.  Coordination with the Site engineers.  Coordination with the client for the ongoing changes in drawings and projects.  Monitoring site engineers work on a daily basis.  Reporting to the GM Projects on the above issues  Responsibilities for safety at the site. (Good working environment). Authorities:  Make or force a required decision at all levels to achieve project objectives.  Initiate actions on the Contractors and consultants for Quality, Quantity and Timeframe issues related to project work.  To stop and initiate corrective actions on non–confirming products/services. Site Supervisor Responsibilities:  Coordinating with all staff for the Quality related issues of Construction.  Daily Labour Handling for Civil Work.  Monitoring of Work progress and daily reporting.  Preparation of work progress report / Quality Documentation.  Control of non – conformities on site  Safety at site / Construction work.
  • 12.  Coordination with the Site Contractor for the daily work requirements.  Coordination with external agencies for calibration of instruments and material testing. Authorities:  Initiate actions on the staff for non-fulfillments of the documentation related quality  To stop and initiate corrective actions on non–conforming products. Site engineer Responsibilities:  Monitoring of site and labour contractors.  Monitoring of work progress and daily reporting  Preparation of work progress report.  Control of non – conformities on site.  Ensuring instruments are properly used and are with the status of calibration.  Track Project progress & produce regular weekly status reports.  Coordinate with all labour contractors to achieve continuous progress at the site as per schedule.  Follow up with the Project manager for pending decisions/drawings/building specifications.  Communicate management decisions and information to Site subordinate staff.  Ensuring the worker’s safety at site and usage of safety equipment.  Implementation and follow up and regular monitoring of implemented ISO 9001 system at the site.  Coordination with the Quality Person for Quality related issues.  Coordinating Material Accountability at site Authorities:  Initiating the corrective and preventive actions as needed on contractors and consultants.
  • 13.  Decision making on during any emergencies at the site. In-charge Marketing: Managing & motivating the sales force towards the achievement of target.  Preparation of Sales plan.  Annual sales forecast.  Monthly sales forecast.  Implementation of sales plan. Authorities:  Approval of documents as per the Master list of Quality System Document.  Authorized to decide corrective & preventive action.  Authorized to obtain concessional acceptance for non – conforming product from the customer. InCharge – ADMIN + ACCOUNT Responsibilities:  Responsible for tendering activity.  Customer order review.  Handling and coordinating customers  Identification of resources, as applicable.  Document & Data control system pertaining to his department.  Maintain all documents related to the quality system.  Coordinator for Management reviews.  Promoting awareness of customer requirements throughout the Organization.  Compliance & effectiveness of the training system.  Suitable working environment (cleanliness, ventilation, lighting, safety etc.).  Record maintaining for Sales Register, Rent Register, Sale Files, Stationery and Office equipment.  Archiving and record keeping of old files.
  • 14.  Payroll Monthly: Salary –To release monthly salary of the employees as per policy finalized.  Leave – To keep the record of leave as per policy finalized.  Annual Allowance – To release annual allowances as per policy finalized.  Employee Record – To update employee details as per organization Policy and QMS.  To prepare an appointment letter, confirmation letter, experience letter & all employee-related matter as per policy finalized with the help of the Managing Director. Authorities:  Approval of customer orders.  Approval of documents as per the master list of Quality System Document.  Authorized to decide corrective & preventive action. In charge Purchase: Responsibilities:  Overall in charge of purchase activities.  Identification of resources, as applicable.  Purchasing system – Evaluation, selection, purchasing, monitoring.  Document & Data control system pertaining to his department.  Corrective / Preventive action system (subcontractor non- conformances, in particular.)  Control of records Authorities:  Authorized to review & approve purchasing documents.  Authorized to select & discontinue sub-contractor 6.0 Planning 6.1 Actions to address risks and opportunities
  • 15. 6.1.1 Xxx is addressed the issues, requirements the risks and opportunities 1. give assurance that the quality management system can achieve its intended result(s) 2. Enhance desirable effects 3. Prevent, or reduce undesired effects 4. achieve improvement 6.1.2 1. actions to address these risks and opportunities 2. How to 1. integrate and implement the actions into its quality management system processes 2. Evaluate the effectiveness of these actions Interested parties Requirements Risks and Opportunities Effectiveness of action External providers Communication, Payment Terms, On Time Supply, Technology Support, Communication Gap, Payment & Delivery terms not in written, Output Failure Communication like Emails, Phone, Payment & delivery te mention in PO, Documented informati provided for Technical support Customer Product Quality, Delivery & service of on time, Response to the complaint, Proper Communication channel Business Loss, Reputation Down for Organization Defined in the documen information of Marketi & Sales process & Rev in Management review meetings
  • 16. Statutory & Regulatory Body Organization & product related Statutory & regulatory requirements are kept The customer is not acceptable material or loss of business Defined in documented information & Review Management review meetings Bankers/financiers All product & organization related documents are kept The organization is facing the problems (funds related) All product & organiza related documents are Employees On time Payments Work is not properly operated On time payments issu employees Marketing Competitive rates, More amenities, Prime Location, Organization facing problems in sales, Reputation in market Market analysis, Competent marketing t Purchase Competitive rates, Good Quality material, Timely Delivery, The organization facing Finance problems, Customer dissatisfied, Delay in project completion & Reputation in market Market analysis, Competent Purchase 6.2.2 Quality objectives and planning to achieve them 6.2.1 Xxx establishes quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives shall 1. Be consistent with the quality policy 2. Be measurable 3. Take into account applicable requirements 4. Be relevant to the conformity of products and services and to the enhancement of customer satisfaction 5. Be monitored
  • 17. 6. Be Communicated 7. Be updated as appropriate 6.2.2 Xxx achieve its quality objectives, 1. What will be done? 2. What resources will be required? 3. Who will be responsible? 4. When it will be completed 5. How the results will be evaluated Our Quality Objectives are as below:  Timely completion of projects  Energy Generation Per Year  Increase Customer satisfaction  Reduce Customer Complaint 6.3 Planning of changes Xxx determines the need for changes to the quality management system, the changes are carried out in a planned manner 1. the purpose of the changes and their potential consequences 2. the integrity of the quality management system 3. the availability of resources 4. the allocation or reallocation of responsibilities and authorities Xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes 7 Support 7.1 Resources 7.1.1 General Xxx is determined and provides the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system. Xxx is consider
  • 18. 1. the capabilities of, and constraints on, existing internal resources 2. what needs to be obtained from external providers HR determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirement. The resources will be in the form of  Human resources including qualified personnel for verification activities.  Manufacturing machines, Test Equipment’s & infrastructure.  Provide raw material & other inputs for the realization of the product.  Providing funds. The Required resources are identified in the event of new Process Development / Business plan review, Mfg Process Flow, also based on the Organization performance review in MRM and monthly business reviews. 7.1.2 People Xxx determines and provides the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. HR along with respective processes IN CHARGE ensures that personnel performing work affecting product quality is competent and training to give on the basic operation and control of its processes. 7.1.3 Infrastructure Xxx is determined, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Infrastructure can include 1. buildings and associated utilities 2. equipment, including hardware and software 3. transportation resources 4. information and communication technology
  • 19. At Xxx management determine, provide and maintain the infrastructure needed to achieve conformity to product requirements & in identifying the required resources the PARTNER play a key role based on their day to day interactions with respective IN CHARGE’s and employees 7.1.4 Environment for the operation of processes Xxx is determined, provide and maintain the environment necessary for the operation of its processes and toachieve conformity of products and services. A suitable environment can be a combination of human and physical factors 1. Social (e.g. non-discriminatory, calm, non-confrontational) 2. Psychological (e.g. stress-reducing, burnout prevention, emotionally protective) 3. Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). Project in coordination with respective IN CHARGE determines and manages the work environment needed to achieve conformity to product requirement and reviewed ongoing basis. 7.1.5 Monitoring and measuring resources 7.1.5.1 General Xxx is determined and provides the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided 1. are suitable for the specific type of monitoring and measurement activities being undertaken 2. are maintained to ensure their continuing fitness for their purpose Xxx is retained appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources 7.1.5.2 Measurement traceability
  • 20. Xxx is measurement traceability is maintained requirement if applicable for the instruments or is considered by them to be an essential part of providing confidence in the validity of measurement results, 1. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information 2. identified in order to determine their status 3. safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results Xxx is determined the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. Control of Monitoring & Measuring Equipments. The measurement & Monitoring system is well equipped and the system has complete control over the monitoring and Measuring Equipment. The measurement methods used are evaluated to ensure that they are appropriate and reliable. To ensure that the measuring equipment operates effectively and give reliable results, we have taken the following steps:  Equipments are maintained properly and are calibrated & adjusted as and when needed. Necessary safeguards are in place to take care of adjustments that could lead to invalid results.  Calibrations are carried out as per national standards (by NABL accredited laboratories only). Where no such standard exists, the basis used for calibration or verification is recorded. The calibration records include the last date of calibration, calibrating agency (for the external agency), calibration result, and frequency of calibration as per the process and/or instrument requirement and the next calibration date. The required accuracy is identified and compared to the measurement that meets expectations.
  • 21.  Identification of appropriate equipment is accomplished by tagging, labelling, numbering or by including it in a calibration/maintenance database.  Proper control is maintained to ensure that no faulty equipment is used, the reliability of the equipment is ensured through routine maintenance and re-calibration.  Equipments are used, handled and stored under conditions that protect the accuracy and prevent. Unauthorized adjustment. Work environmental controls are all in place for equipment.  Instrument history cards are maintained for all measuring & Test Instruments. Laboratory Requirements Internal Laboratory The internal laboratory is available as on date the various test is carried out as per customer requirement, standard specification and internal laboratory test procedure are available & the record is kept. External Laboratory  External / Commercial/independent laboratory facilities used by IM will be accredited laboratory facilities to NABL or NPL or as accepted by the Customer.  Evidence of acceptance by national accreditation or customer shall be kept. 7.1.6 Organizational knowledge Xxx is determined the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Organizational knowledge is specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives. Organizational knowledge can be based on:
  • 22. 1. Internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services); 2. External sources ( e.g. standards; academia; conferences; gathering knowledge from customers or external providers). 7.2 Competence Xxx is 1. Determine the necessary competence of person(s) doing work under its control that affects the Performance and effectiveness of the quality management system 2. Ensure that these persons are competent on the basis of appropriate education, training, or Experience 3. Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken Retain appropriate documented information as evidence of competence for all employees 7.3 Awareness Xxx is ensured that persons doing work under the organization’s control are aware of 1. The quality policy 2. Relevant quality objectives 3. Their contribution to the effectiveness of the quality management system, including the benefits of improved performance 4. The implications of not conforming to the quality management system requirements 7.4 Communication Xxx is determined the internal and external communications relevant to the quality management system, including 1. On what it will communicate 2. When to communicate
  • 23. 3. With whom to communicate 4. How to communicate 5. Who Communicates INTERNAL COMMUNICATION What When with whom How Who Quality policy Permanent All Employees / Interested parties Display / Letter / Training Manage Importance of effective QMS As per the Training plan / during Orientation training All Employees Training / Display Manage Responsibilities and Authority During recruitment / Promotion / Department change Employee Procedure / Oral / Training Manage Quality objectives While defining / Once in 3 months All employees Procedure / Oral / Training Manage Customer complaint / Feedback At the time of receipt Head of the department / Respective process owner Meeting Director External COMMUNICATION
  • 24. What When with whom How Who Information to external providers Placing purchase order / Quotation collection Supplier (External provider) Purchase order / Letter / Email / Oral Purch I/C Product information Enquiry stage Customer Email / Website / Catalogue / Letter Direct Enquiry, order, amendments Enquiry review / Order review Customer Electronic media / Letter/ oral Direct Customer feedback Once in a year / After service Customer Forwarding customer feedback form Direct The action is taken for customer complaints Once the action is taken Customer Electronic media / Letter/ oral Direct Information to external providers As agreed with the customer Customer Delivery challan / Letter / Email Stores 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating XXX creating and updating documented information, the XXX is ensured appropriate a) Identification and description b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic)
  • 25. c) Review and approval for suitability and adequacy XXX’s quality management system is included Quality Management System documentation is established with the following approach. A four-level-documented structure is followed for the operation of the Quality Management System. L- 1 QUALITY MANUAL (Standard Requirement) L- 2 PROCEDURES L- 3 PROCESS FLOW CHART, WI, QUALITY PLANS, CHECKSHEETS, MANUFACTURING PROCESS FLOW CHARTS L- 3 DOCUMENTED INFORMATION  Level 1: Quality Manual (standard Requirement) Defines the approach and responsibility, which includes a documented statement of quality policy & objectives etc.  Level 2: Procedures Defines what, where, when, who & why of an activity being done as stated in ISO- 9001:2015 standard. The documented procedure activity process flowchart defines the effective planning, operation and control of processes.  Level 3: WI, Quality Plans, Check sheet etc Defines how exactly an activity is to be done ensuring the effective planning, operation and control of processes.  Level 4: Documented Information Provides the evidence, which has to be established for all the activities, stated above which In turn Documented Information. A master list of Quality Record is maintained by respective Departments/ section heads as per the requirement of ISO 9001:2015.
  • 26. Control of Quality System Manual.  Partner is approved the Quality Manual, procedure, WI & documented Information and its amendments.  Management Representative / Quality In charge is responsible for the preparation, review, issue & control of the manual and its amendments.  In case any person ceases to be the holder of manual copy for any reason, his copy number of manual will be allocated to any new holder with the note in amendment list to this effect.  MASTER COPY will be stamped “MASTER” on the front side of all pages in “BLUE”  A photocopy will be taken for all MASTER & will be “CONTROLLED” stamped in RED MR/Quality in charge maintains the master copy having original signatures. Document changes. MR/Quality in charge perceives the need for the amendment to this manual based on the adequacy audit report, mistake/corrections during review by any holder, system change, and an amendment to reference ISO standard or any change in the organization affecting system described in this manual. Amendments to this manual are recorded in the Amendment list (After Amendment). The holders of the Quality System Manual refer to the amendment list before referring to respective amended sections to clearly understand the details/purpose of the amendment. A list indicating the latest revision status of each page of this manual, whenever a page of any chapter is amended, the page and the chapter bear the latest Rev. No. The latest revision no. is indicated in the amendment sheet, and on the cover page of the Quality Manual. The revised version of the document pages is sent only to the holders as along with the updated amendment list and revision status page. Controlled copyholders of this manual should ensure that the obsolete pages are removed & destroyed and revised pages are inserted in the Manual at appropriate places. Management Representative / Quality In-charge maintains one copy of the obsolete version of revised pages at the time of each amendment for reference purposes and having the OBSOLETE stamp in RED color. When the Rev. No. Of
  • 27. the Amendment, sheet reaches 09, or in case an amendment to ISO standard is released, the entire manual will be reissued and bear the next serial number of issue no. No details of amendments to earlier issue and recorded in amendment list for the new issue. Numbering Logic Of Quality System Manual : The numbering logic of this quality system manual will be as described here: 1. The numbering logic will be -QM-XX. 2. indicates xxx. 3. QM indicates Quality System Manual of ISO 9001:2015. 7.5.3 Control of documented information 7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure 1. It is available and suitable for use, where and when it is needed. 2. It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity) 7.5.3.2 For the control of documented information, xxx is address the following activities, as applicable 1. Distribution, access, retrieval and use 2. Storage and preservation, including preservation of legibility 3. Control of changes (e.g. version control) 4. Retention and disposition Documented information of external origin determined by the organization to be necessary for the Planning and operation of the quality management system is identified as appropriate and is controlled. Documented information retained as evidence of conformity shall be protected from unintended alterations. 8 Operation 8.1 Operational planning and control
  • 28. Xxx will plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions in & maintained risks and opportunities related to planning maintained in operational planning control. The bar chart for planning are 1. Determining the requirements for the products and services 2. Establishing criteria for 1. The processes 2. The acceptance of products and services 3. Determining the resources needed to achieve conformity to the product and service requirements 4. Implementing control of the processes in accordance with the criteria 5. Determining, maintaining and retaining documented information to the extent necessary 1. To have confidence that the processes have been carried out as planned 2. To demonstrate the conformity of products and services to their requirements Xxx is control planned changes and reviews the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. Xxx is ensuring that outsourced processes are controlled. 8.2 Requirements for products and services 8.2.1 Customer communication Communication with customers is include 1. Providing information relating to products and services 2. Handling inquiries, contracts or orders, including changes 3. Obtaining customer feedback relating to products and services, including customer complaints 4. Handling or controlling customer property 5. Establishing specific requirements for contingency actions, when relevant
  • 29. Customers are communicated regarding the product information through the letter, verbal, and/ or through phone, Fax, e-mail. If any amendments in inquiries, purchase orders it will be communicated through Phone, letter & Email. The customer complaints are registered in the customer complaint register and the corrective action taken is communicated. 8.2.2 Determining the requirements for products and services When determining the requirements for the products and services to be offered to customers, the Xxx is ensuring that 1. The requirements for the products and services are defined, including 1. Any applicable statutory and regulatory requirements 2. Those considered necessary by the organization 2. The organization can meet the claims for the products and services it offers At present, the marketing activities are looked after by Marketing in charge and both of them are actively involved in the determination of customer requirements and for each enquiry, he determines the  Requirements related to the product in contract review form with respect to requirements specified by the customer, including the requirements for delivery and post-delivery activities.  Requirements not stated by the customer but necessary for specific or intended use (where Known)  Statutory and Regulatory requirements related to the product  Any additional requirements determined by the organization. 8.2.3 Review of the requirements for products and services 8.2.3.1 Xxx is ensuring that it has the ability to meet the requirements for products and services to be offered to customers. Xxx is conducting a review before committing to supply products and services to a customer, to include 1. Requirements specified by the customer, including the requirements for delivery and post-delivery activities.
  • 30. 2. Requirements not stated by the customer, but necessary for the specified or intended use, when known. 3. Requirements specified by the organization. 4. Statutory and regulatory requirements applicable to the products and services. 5. Contract/order requirements differing from those previously expressed Xxx is ensuring that contract or order requirements differing from those previously defined are resolved. The customer’s requirements are confirmed by Xxx is before acceptance, when the customer does not provide a documented statement of their requirements 8.2.3.2 Xxx is retain documented information, as applicable 1. On the results of the review 2. On any new requirements for the products and services  IN CHARGE MKT shall review the requirement related to the product. This review takes place as and when a new P.O or verbal order is placed/confirmed by the customer for a new part no. and prior to the commitment taken to supply the products.  The review ensures that 1. the product requirements are defined 2. Contract/order requirements differing from those previously expressed in the proposal or quote are resolved. 3. Our organization has the ability to meet the defined requirements 8.2.4 Changes to requirements for products and services Xxx is ensured that relevant documented information is amended, and those relevant persons are made aware of the changed requirements when the requirements for products and services are changed 8.3 Design and development of products and services 8.3.1 General
  • 31. Xxx is establishing, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. 8.3.2 Design and development planning Xxx is considering In determining the stages and controls for design and development, including 1. Nature, duration and complexity of the design and development activities 2. The required process stages, including application design and development reviews 3. The required design and development verification and validation activities 4. The responsibilities and authorities involved in the design and development process 5. The internal and external resource needs for the design and development of products and services 6. The need to control interfaces between persons involved in the design and development process 7. The need for involvement of customers and users in the design and development process 8. The requirements for the subsequent provision of products and services 9. The level of control expected for the design and development process by customers and other relevant interested parties. 10. The documented information needed to demonstrate that design and development requirements have been met. 8.3.3 Design and development inputs Xxx determines the requirements essential for the specific types of products and services to be designed and developed. Xxx is consider 1. Functional and performance requirements 2. Information derived from previous similar design and development activities 3. Statutory and regulatory requirements
  • 32. 4. Standards or codes of practice that the organization has committed to implement 5. Potential consequences of failure due to the nature of the products and services Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs is resolved. Xxx is retain documented information on design and development inputs. 8.3.4 Design and development controls Xxx is applying controls to the design and development process to ensure that 1. The results to be achieved are defined 2. Reviews are conducted to evaluate the ability of the results of design and development to meet requirements, 3. Verification activities are conducted to ensure that the design and development outputs meet the input requirements. 4. Validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use, 5. Any necessary actions are taken on problems determined during the reviews, or verification and validation activities. 6. Documented information of these activities is retained 8.3.5 Design and development outputs Xxx ensure that design and development outputs 1. meet the input requirements 2. are adequate for the subsequent processes for the provision of products and services 3. include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria 4. specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision
  • 33. Xxx is retain documented information on design and development outputs 8.3.6 Design and development changes Xxx is identifying, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. Xxx is retain documented information on 1. Design and development changes 2. The results of reviews 3. The authorization of the changes 4. The actions are taken to prevent adverse impacts 8.4 Control of externally provided processes, products and services (Purchase) 8.4.1 General Xxx is ensuring that externally provided processes, products and services conform to requirements, Xxx determines the controls to be applied to externally provided processes, products and services when 1. Products and services from external providers are intended for incorporation into the organization’s own products and services 2. Products and services are provided directly to the customer(s) by external providers on behalf of the organization. 3. A process, or part of a process, is provided by an external provider as a result of a decision by the organization Xxx determines and applies criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations. IN CHARGE Purchase ensures that the purchased products are procured from Approved sources only and which conforms to specified purchase requirements. This is done as per the business
  • 34. process flow for PROCUREMENT. The type and control to be exercised on the supplier, based on the effect of the purchased product on the process/final product, is defined in the Approved Supplier List. IN CHARGE Purchase evaluates and select supplier based on their ability to supply product in accordance with the requirements of the organization. Criteria for selection, evaluation, and re-evaluation are described and depicted in the Business Process Flowchart. 1. Selection, Evaluation and approval of suppliers 2. Periodical evaluation of Supplier 3. Approved Supplier List will be maintained by the IN CHARGE Purchase and also the records of their periodical performance. 8.4.2 Type and extent of control Xxx ensures that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers Xxx is 1. Ensure that externally provided processes remain within the control of its quality management system 2. Define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output 3. Take into consideration 1. The potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements 2. The effectiveness of the controls applied by the external provider 4. Determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements 8.4.3 Information for external providers
  • 35. Xxx ensures the adequacy of requirements prior to their communication to the external provider. Xxx is communicating to external providers its requirements for 1. The processes, products and services to be provided 2. The approval of 1. Products and services 2. Methods, processes and equipment 3. The release of products and services 1. Competence, including any required qualification of persons 2. The external providers’ interactions with the organization 3. Control and monitoring of the external providers’ performance to be applied by the organization 4. Verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises The Purchase order describes the product to be purchased including 1. Requirement of Material Test Certificate / Dimensional report / PPAP such as Control Plan / Process Flow Chart / Process Sheets / Process Capability studies etc. 2. Requirements for qualification of personnel 3. QMS requirements. PO will be reviewed for adequacy of the specified requirement prior to release by IN CHARGE Purchase & M.R. The Purchase order released to the supplier indicates the intended verification arrangements and method of product release, whenever KWS or its customer intends to perform such verification at external providers end. Incoming Product Quality The control / Inspection plan for incoming be based on the control exercised on the external providers 1. Inspection and/or testing on sampling method. The sampling size should be decided based on past performance of the supplier. 2. Inspection at Sub-contractor’s premises with/without system audit.
  • 36. 3. Quality assurance certificate or the test report from the supplier. 4. Part evaluation by accredited laboratories. 5. Receipt and evaluation of statistical data. 6. Any of above method or Combination of any two or more from above. Supplier Monitoring External providers performance monitoring through the following indicators, & will be carried out by IN CHARGE PUR as described in Procedure for Purchase. Delivered Product Quality.  Delivery Performance.  Customer disruptions including field Returns.  Customer notification Related to quality Or delivery Issues  Premium freight. Xxx promotes monitoring of the performance of manufacturing processes of the external providers’ as part of supplier development. 8.5 Production and service provision 8.5.1 Control of production and service provision Xxx is implemented production and service provision under controlled conditions. Controlled conditions include, as applicable 1. The availability of documented information that defines 1. The characteristicsof the products to be produced, the services to be provided, or the activities to be performed 2. The results to be achieved 2. The availability and use of suitable monitoring and measuring resources 3. The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services have been met
  • 37. 4. The use of suitable infrastructure and environment for the operation of processes 5. The appointment of competent persons, including any required qualification 6. The validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement; 7. The implementation of actions to prevent human error 8. The implementation of release, delivery and post-delivery activities Production In-Charge shall plan the production as per and respective Section In-charge carry out the process under the controlled condition as defined in Process Flow in respective process procedures. Controlled conditions shall include:- 1. Production plans for all processes which describes the characteristics of the product and process flow chart for the sequence of operations 2. Work Instructions made available at all workstations. 3. Use of appropriate equipment for a particular process/operation 4. Use of calibrated monitoring and measuring devices 5. In process inspection/verification 6. Verification of acceptance criteria Production Plan The production plan for all stages of production, including receipt of the material sample, pilot & regular production shall be used. These Production plans at each stage may be amendments of production plans of the earlier stage. As described above, Marketing shall be involved in the preparation of production plans where required by customer production Plans will be submitted to the customer for approval. The production plan shall  list the controls used for the manufacturing processes  Include methods for monitoring of control exercised over special characteristics defined by both the customer and the organization.
  • 38.  Include the customer required information if any  Initiate the specified reaction plan when the process becomes unstable or not statistically capable production plans shall be reviewed and updated, as appropriate:  The product is changed.  The manufacturing processes are changed.  The processes become unstable.  The processes become non-capable.  Inspection frequency and method changes  Change in supply sources  Corrective actions based on process NC,s & customer concerns  Drawing changes / ECNs. Production plans are developed for all the processes involved in the manufacturing by the Cross-functional team. These are identified during the advanced product planning process. Wherever approvable. The production plans are live documents and are reviewed and updated when the change to the original product or process occurs. Work Instructions Respective IN CHARGE prepares Work Instructions for all operations/process activities and for all employees having responsibilities under them. These instructions are made accessible for use at the work station& are prepared based on trial run result and old documents of the similar product at the time of job induction into production and will be reviewed for applicable changes in event of production Plan change(s). Preventive Maintenance IN CHARGE MNT maintains a list of all machines/equipment used in production and designated key process equipment in the list. A plan for preventive maintenance for this key equipment shall be developed & implemented to ensure continuous process capability. This plan shall be based on the available data from the manufacturer’s recommendations, previous breakdown and preventive history, the extent of usage, and rate of wear and tear, etc., based on these details appropriate predictive techniques are used. IN CHARGE MNT ensures
  • 39. that required spare-parts for a replacement along with other resources for maintenance as per preventive maintenance schedule are available in time. Appropriate records of maintenance shall be maintained by IN CHARGE MNT. A system that describes the planned & predictive maintenance method is detailed in Procedure respectively. Validation of processes for production and Service Provision All processes are validated before the start of the production through set up approval and First Five Piece Inspection. The above processes are controlled and continually monitored through documented work instructions, process qualifications, set up approval, and worker qualification, as applicable to ensure that the specified requirements are met. Appropriate records are maintained by All IN CHARGE to demonstrate the control of these processes and equipment. Records of personnel qualifications and re-qualifications are maintained by All IN CHARGE. Stipulate workmanship standards to the greatest practicable extent, where appropriate, by means of written standards, representative samples, or display boards. Ensure Handling, Storing, and transporting within the production shop are carried to protect all materials/products. The details of process controls are described in respective department procedures. 8.5.2 Identification and traceability Xxx is used suitable means to identify outputs when it is necessary to ensure the conformity of products and services. Xxx has identified the status of outputs with respect to monitoring and measurement requirements throughout production and service provision. Xxx is controlling the unique identification of the outputs when traceability is a requirement and shall retain the documented information necessary to enable traceability. All material is identified including inspection and test status inappropriate manner (paint, punch mark, labels, stickers, and tagging, etc.) from receipts at stores through various stages of production. The final product is kept on trolleys & transferred to the Finished Goods area before delivery to the customer as detailed in work procedures for storage, packing & dispatch procedure. Traceability is provided, if required by the customer or decided for some products by KWS to identify finished products by
  • 40. providing punch mark/tag/batch code. For such products, proper records are maintained also the main packages are traceable through the Barcode system. 8.5.3 Property belonging to customers or external providers Xxx is exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization Xxx identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred  Any arrangement of Customer Supplied raw materials, components, tooling, returnable packaging, measuring instruments, etc., are identified during the contract review by CFT/ IN CHARGE MKT and communicated to the people concerned.  All such products are uniquely identified after proper verification and properly stored and maintained. Any such product that is lost damaged or is otherwise unsuitable for use shall be recorded and reported to the Customer by customer representative & IN CHARGE Marketing. It shall be the responsibility of QA personnel to verify the quality of such product even if it has been supplied by the Customer 8.5.4 Preservation Xxx preserves the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. Preservation includes identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. At all stages of production, appropriate material/product handling, storage, packing of products, preservation, and delivery of products established viz. The material in storage – is preserved by packing in
  • 41. Gunny bags. In-process – the material is stored in Bins and Air Bubble bags. Finished goods – All parts are surface coated & packed in BINS with Plastic coverage. Storage and Inventory A suitable inventory control system is established to optimize inventory turns, assure stock rotation & minimize inventory levels. Stores Section shall monitor stock levels and inform the purchase section in time & FIFO is emphasized. Handling and Storage of Incoming Material At present manual methods are provided for the movement of brought- out items and raw material respectively. In charge, Stores shall ensure safe handling of materials/items received in stores. Secured storage space with proper environmental conditions to protect the products stored shall be provided for all items in stores. Shelf-life items are identified and periodic inspection of all stored items is conducted once in three months for fitness for use. Store In-charge has the defined responsibility to receive issue & dispatch materials from secured storages i.e., Stores & Finished Goods Stock point. All material in stock is periodically assessed to verify continued fitness for use. The proper material accounting shall be maintained in the stock ledger, with the consideration for keeping stored items in usable conditions. In process Products Handling of In-process material is done using Trollies and BINS. At all times the individual operator ensures safe handling of the material to prevent damage. Storage on the shop floor, for in-process products, if required suitable packaging material will be used to protect the products from any kind of damages, deterioration due to environmental conditions. Finished Products Finished products are handled carefully with the use of hydraulic Trollies and packed by using BINS and Polythene bags, so as to protect
  • 42. them from any kind of damage and kept in Finished goods area is the duly cleaned condition. All finished products stored will be under the control of the assembly in charge. Packaging The packaging of products carried out according to packaging instructions/drawings wherever applicable, i.e., contractually agreed or if product nature calls for packing. Type of packaging material & its quality is ensured as per customer requirements if mentioned in the purchase order. Material/packages used for the packing of products are verified before packing to ensure its conformance to specified requirements as per Purchase Order/ Customer Requirement. The packing method employed will be adequate to protect the products fully till they reach their destination if contractually specified. 8.5.5 Post-delivery activities Xxx is meet requirements for post-delivery activities associated with the products and services Xxx considers In determining the extent of post-delivery activities that are required, 1. statutory and regulatory requirements 2. the potential undesired consequences associated with its products and services 3. nature, use and intended lifetime of its products and services 4. customer requirements 5. customer feedback Delivery The product quality is protected after final inspection & testing and wherever contractually specified extended from delivery to destination. The deliveries of products are done as per contract terms/delivery schedules for the customer. 8.5.6 Control of changes Xxx is review and control changes for production or service provision, to the extent necessary to ensure continuing conformity
  • 43. with requirements. Xxx is to retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review. 8.6 Release of products and services Xxx implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. Xxx is retain documented information on the release of products and services. The documented information includes 1. Evidence of conformity with the acceptance criteria 2. Traceability to the person(s) authorizing the release To ensure that the products manufactured meet the quality requirements of customer fully, a systematic approach for inspection and testing at all stage viz. incoming, in the process and final are demonstrated. At each stage, the activity is performed according to documented procedures. Receiving Inspection & Testing Inspection / Verificationof incoming material is carried out according to the respective Incoming Inspection Standards & Control plans. This is the responsibility of IN CHARGE QA. The control plan for incoming shall use one of the following methods –  Inspection and/or testing on sampling method.  Inspection at suppliers premises with/without system audit.  Quality assurance certificate or the test report from the supplier. The incoming materials used in production shall not be used or processed without acceptance by Receipt inspection. Store Personnel are responsible for receipt, identification, records and storage of all Incoming materials, the detailed procedure for incoming material inspection is described.
  • 44. In-process Inspection & Testing All in-process inspections carried out according to the applicable control plans by QA during in process based on sample inspection and as per the documented procedures for the required tests. The details of in-process inspection are described in the respective process owner’s procedure Inspection and Tests Records Records of inspection/tests at all stages mentioned above are prepared in specific forms & maintained. The format-number(s) of records as mentioned in respective procedures/work instructions /control plans. IN CHARGE QA & IN CHARGE PRD will be the approving authority at each stage for the disposition of non- conforming materials/products. The system of handling of non- conforming materials/products is described in 8.7 Control of nonconforming outputs Procedures are established for identifying non-conforming product at Stores and stages of production/inspection as well as at the final inspection stage. The non-conforming materials are identified by the production operator/ QA Personnel at these stages and suitably identified. Responsibility and authority are assigned for segregation, review and disposition of non-conforming product. Documented information of segregation, review and suitable disposition of non- conforming materials are maintained by QA Personnel. Who is authorized to review the non-conforming product? The decisions of review as per application for disposition may be  The action which has to be taken to eliminate the non-conforming situation.  Use as it is under concessions (deviation) / with partial rework or without rework after approval from defined Authorization.  Rework to meet specifications.  Reject / scrap.  Return to the supplier.  Regard for alternative applications.  Reworked / Repaired product re-verified to demonstrate conformity to the requirement in accordance with the documented
  • 45. control plan. Details for the handling of nonconforming outputs are described in Procedure 9 Performance evaluations 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General Xxx is evaluating the performance and the effectiveness of the quality management system. Xxx is retaining appropriate documented information as evidence of the results. Purpose: To establish measurement, analysis and improvement plan for all the process / Function defined in the Quality Management System. Objective: To establish quality management measurement process and monitor as per planned results for achievement also establish processes to identify non-conformity situation and subsequently corrective & preventive actions to be taken. IN CHARGE QA in consultation with all respective production process heads plan and implement the monitoring, measurement, analysis, and improvement processes needed. 1. What needs to be monitored and measured 2. The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results 3. When the monitoring and measuring shall be performed 4. When the results from monitoring and measurement are analysed and evaluated 9.1.2 Customer satisfaction Xxx is to monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. Xxx is determined the methods for obtaining, monitoring, and reviewing this information. The MKT In Charge has primary responsibility for Customer Satisfaction as one of the measurements of the Quality Management System and as to whether the organization has met customer requirements. Customer satisfaction shall include the
  • 46. collection of authentic data, frequency, and validity of the analysis. The trend and major elements affecting customer satisfaction and key indicators of customer dissatisfaction will be monitored supported by objective evidence. Wherever data available, the level of customer satisfaction will be compared with those of our competitors & a relevant action plan will be evolved. A customer satisfaction analysis survey will be conducted ONCE IN A 12 MONTHS Review of customer satisfaction will be taken by top management during Management Review Meeting as described in Procedure. 9.1.3 Analysis and evaluation Xxx is analyzed and evaluates appropriate data and information arising from monitoring and measurement. The results of the analysis are used to evaluate 1. Conformity of products and services 2. The degree of customer satisfaction; 3. The performance and effectiveness of the quality management system; 4. If planning has been implemented effectively; 5. The effectiveness of actions taken to address risks and opportunities; 6. The performance of external providers; 7. The need for improvements to the quality management system 9.2 Internal audit Procedures are established for a system of planned and documented internal quality audits to verify that the Quality Management System conforms to the planned arrangements as per ISO 9001:2015 requirements and effectively implemented and maintained. The MR is responsible for:  Planning and organizing audits at works depending on the importance and the extent of the activity concerned and the results of the previous audits. The internal quality system audits
  • 47. as per schedule are to be carried out at least once in SIX Months period and at least 02 times during a year.  MR also ensures that the trained auditors are involved in quality system audit to ensure the objectivity of the auditing processes and are not directly responsible for the area under audit. The results of the audit are documented in the specified format to record non-conformances in product/process and work practices and brought to the notice of the person responsible for the area audited, who in turn shall take appropriate corrective actions within the agreed time limit and ensure removal of deficiencies observed. Follow up on the effectiveness of the corrective action taken.  The effectiveness of identified corrective action against any such internal audit findings is verified by the MR prior to subsequent management review meetings and recorded.  MR is responsible for ensuring that non-conformances observed during IA are closed by appropriate corrective action implementation in a defined period.MR identifies and marks the corrective actions needing confirmation for their effective implementation and also arranges for the verification in subsequent audits or follow-up audits will be planned.  MR maintains appropriate records of implementation & effectiveness in the form of internal audit reports. The details of the audit team, schedule, preparation of non-conformances reports,  The follow up on the corrective actions is detailed in the procedure for corrective action  The nonconformance identified during third-party audits or by external agencies is handled in the same manner. The non- conformances of IA remaining open due to a delay in the implementation of corrective action along with major non- conformances recorded will be reviewed during management review meetings. 9.3 Management review 9.3.1 General Top management of Xxx is reviewing the organization’s quality management system, at planned intervals, to ensure its continuing
  • 48. suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. Management review will be conducted and chaired by MD once in SIX Months to ensure continuing suitability & effectiveness in satisfying the requirements of ISO 9001:2015 and the stated quality policy and objectives. The Management Review will include all elements of the entire quality system as detailed in the procedure and schedule for the Management Review. Records of Management Review Meetings shall be maintained by MR. The Director during review shall assess opportunities for improvement and the need for changes in the Quality Management System, including the Quality Policy and Quality Objectives. 9.3.2 Management review inputs The management review is planned and carried out taking into consideration 1. The status of actions from previous management reviews 2. Changes in external and internal issues that are relevant to the quality management system; 3. Information on the performance and effectiveness of the quality management system, including trends in:  customer satisfaction and feedback from relevant interested parties;  the extent to which quality objectives have been met;  process performance and conformity of products and services;  nonconformities and corrective actions;  monitoring and measurement results;  audit results;  the performance of external providers 4. The adequacy of resources; 5. The effectiveness of actions taken to address risks and opportunities; 6. Opportunities for improvement 9.3.3 Management review outputs
  • 49. The outputs of the management review shall include decisions and actions related to: 1. Opportunities for improvement; 2. Any need for changes to the quality management system; 3. Resource needs. The Xxx is retain documented information as evidence of the results of management reviews 10 Improvement 10.1 General Xxx determines and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These include 1. Improving products and services to meet requirements as well as to address future needs and expectations. 2. Correcting, preventing or reducing undesired effects; 3. Improving the performance and effectiveness of the quality management system. Improvement is included correction, corrective action, continual improvement, breakthrough change, innovation, and re- organization. 10.2 Nonconformity and corrective action 10.2.1 When nonconformity occurs, including any arising from complaints, Xxx is  All nonconformities relating to product, process and quality system are investigated & the results are recorded. While investigating the causes of non-conformances & deciding corrective actions, the team identifies other products/situations where same or similar nonconformance can occur.  Corrective actions for nonconforming products and processes, detected in the organization are recorded; analyzed, reviewed and necessary actions are taken. This will be the responsibility of IN CHARGE QA & PRD (respective production process In-charge) the
  • 50. corrective action and preventive measures are implemented and their effectiveness is monitored. The details are as described in the procedure. Corrective actions are taken on customer complaints; by analyzing the causes of the complaints and taking suitable action to prevent their reoccurrence. The effectiveness of the identified corrective action is monitored through customer feedback and also the customers are kept aware of the corrective actions initiated, with each identified corrective action. 10.3 Continual improvement Xxx continually improved the suitability, adequacy, and effectiveness of the quality management system. Xxx considers the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of the continual improvement